FDA 510(k)
K123030
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Ships from U.S. warehouse
30-Day Returns
Eligible products
1-Year Warranty
Limited product warranty
MCN-S600F Compressor Nebulizer for Adult Home Use
Sale price
$59.99
Regular price
$69.99
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MCN-S600F Compressor Nebulizer for Adult Home Use
Reliable compressor aerosol delivery designed for adult home care.
Sale price
$59.99
Regular price
$69.99
✓ FDA 510(k) cleared (K123030)
✓ ≥0.2 mL/min average nebulization rate
✓ 8 mL medication cup
✓ Adjustable aerosol output
✓ 1-year limited warranty
✓ 30-day returns
FREE U.S. SHIPPING
Estimated delivery: 2–5 business days
Use this device only as directed by your licensed healthcare professional and in accordance with applicable prescription requirements.
HOME NEBULIZER THERAPY
A Compressor Nebulizer Built for Home Use
The MCN-S600F is a compressor nebulizer intended to deliver aerosol treatments prescribed by a physician to adults in the home. Its AC-powered compressor drives airflow through the nebulizer cup, turning liquid medication into a fine aerosol.
It plugs into a standard 120V outlet, has a single power switch, and includes an adjustable ventilation paddle on the nebulizer cup to change aerosol output.
Key Specifications
≥0.2 mL/min
Average Nebulization Rate
2.81 ± 0.14 μm
MMAD
6–10 L/min
Air Flow Range
<65 dBA
Specified Noise Level
*Measured with sodium chloride solution. Results may differ with other medications, suspensions or viscous solutions.
SIMPLE SETUP
Four Steps to Get Started
Before first use: clean and disinfect the nebulizer kit as described in the Instruction Manual.
Always follow your healthcare provider's instructions regarding medication type, dose and treatment duration. Read the full Instruction Manual before use.
01
Add Medication
Attach the air tube to the nebulizer cup. Fill the cup with the medication prescribed by your healthcare provider (8 mL maximum), then close the cup.
02
Connect the Interface
Connect the mouthpiece or a mask to the nebulizer cup. The mouthpiece is the most effective option; use a mask only if a mouthpiece cannot be used.
03
Begin Treatment
Plug the unit into a power outlet and switch on the compressor. Keep the nebulizer cup upright during treatment. A flow of mist from the cup shows the device is working.
04
Finish and Clean
Switch off and unplug the device, remove the air tube, and clean the nebulizer kit after each use as described in the Instruction Manual. Let all parts dry completely before storing.
Important Safety Information
The MCN-S600F is used to administer aerosol treatments to adults in the home care setting. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. It is intended for use in the patient's home on the order of a physician.
Do Not Use
- If you are not under the direction of a physician for the medication you plan to nebulize
- By patients with severe hypoxia or respiratory failure
- For life support
- Near flammable gases, or in an oxygen-enriched environment
- Together with ventilation systems
- If the device or nebulizer kit is visibly damaged, has been dropped, or makes unusual noises
- By unconscious patients. The device is for conscious, awake patients only
Warnings
- Use only medication prescribed or recommended by your physician or pharmacist. Follow their instructions for type, dose, frequency and duration.
- Apart from medication, use only distilled water or saline solution in the nebulizer cup.
- Essential oils, cough medicines, gargling solutions, and other highly viscous liquids are not suitable for use in this nebulizer.
- Do not fill above the 8 mL maximum. Hold the nebulizer cup upright during treatment.
- Each user must use their own nebulizer kit. Do not share nebulizer kits.
- The air filter must be replaced with a new original filter at least every 30 days, or sooner if dirty, wet or blocked. Do not clean and reuse a used filter.
- Children or people with limited abilities should be supervised by an adult while using the device. Keep the device, small parts and packaging out of the reach of children.
- Keep the unit dry. Do not use it with wet hands or in wet rooms, and do not obstruct the ventilation openings.
- Do not open or attempt to repair the unit. Unplug the device after use.
- Stop using the device and contact your physician if you feel pain or discomfort.
- The device is for private home use only, not for clinical or commercial use.
Possible Side Effects
Some patients may experience chest tightness, cough, discomfort, low oxygen levels, a rapid heart rate, or pale skin around the mouth during aerosol treatment. Contact your physician if you have any concerns.
Reporting
Serious problems related to this device can be reported to the FDA through MedWatch (www.fda.gov/medwatch).
FDA MedWatch
ADJUSTABLE ATOMIZATION
Adjustable Aerosol Output
A ventilation paddle on the nebulizer cup changes how much air is drawn into the cup, which changes aerosol output.
Open: Higher output setting
Partially Closed: Intermediate output setting
Closed Position:Lower output setting
Disclaimer
Use the setting recommended in the Instruction Manual and by your healthcare provider.
What's in the Box
- Compressor Nebulizer Unit (MCN-S600F)
- Nebulizer Medication Cup (8 mL)
- Air Tube (1.6 m)
- Adult Mask
- Mouthpiece
- Air Filters (5 pcs)
- Power Cord
- Instruction Manual
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MCN-S600F Specifications
| Device | Compressor Nebulizer |
| Model | MCN-S600F |
| Power | AC 120V / 60Hz |
| Rated Current | 1.3 A |
| Medication Cup Capacity | 8 mL (maximum) |
| MMAD | 2.81 ± 0.14 μm |
| Average Nebulization Rate | ≥0.2 mL/min |
| Noise | <65 dBA |
| Compressor Pressure | 30–50 psi (206–345 kPa) |
| Operating Pressure | 9.5–20 psi (65.5–137 kPa) |
| Air Flow | 6–10 L/min |
| Operating Temperature | 10°C–40°C (50°F–104°F) |
| Operating Humidity | 10%–90% RH |
| Storage Temperature | −20°C–70°C (−4°F–158°F) |
| Storage Humidity | 10%–95% RH |
| Atmospheric Pressure | 500–1060 hPa |
| Designed Device Life | 3 years |
| Particle Size | Approx. 75.74 ± 0.02% within 0.5–5 μm |
| Nebulization Rate | ≥0.2 mL/min |
| Weight | 1.2 kg (2.65 lb) |
| Device Dimensions | 150 × 142 × 87 mm (5.9 × 5.59 × 3.43 in) |
| Housing Material | ABS |
| Electric Shock Protection | Class II |
| Ingress Protection | IP21 |
| Air Filter Replacement |
At least every 30 days |
*Measured with sodium chloride solution. Results may differ with other medications, suspensions or viscous solutions.
**Designed service life is based on the manufacturer's specified usage conditions (3 treatments per day, about 10 minutes each) and is separate from the 1-year limited warranty. See Purchase Assurance below for warranty terms.
Purchase With Confidence
Free Standard Shipping
Orders are fulfilled from a U.S. warehouse with an estimated delivery of 2–5 business days.
30-Day Returns
Eligible products may be returned within 30 days of delivery, as described in our Returns Policy.
1-Year Limited Warranty
Covers eligible manufacturing defects for one year from purchase.
Regulatory Information
The MCN-S600F is used to administer aerosol treatments to adults in the home care setting, whenever a physician or healthcare professional administers or prescribes medical aerosol products using a small volume nebulizer. The intended environment is the patient's home, on the order of a physician.
- Device: Compressor Nebulizer MCN-S600F (MCN-S600XX series)
- FDA 510(k): K123030
- 510(k) Holder: Dongguan Aidisy Machinery & Electronic Equipment Co., Ltd
- Decision: Substantially Equivalent — December 19, 2013
- Regulatory Class: Class II
- Product Code: CAF
- Regulation: 21 CFR 868.5630 — Nebulizer (direct patient interface)
*Use this device in accordance with its labeling, the Instruction Manual, and your physician's instructions. FDA 510(k) clearance does not denote FDA approval or endorsement of darevona Health or its marketing claims.
Frequently Asked Questions
What is the MCN-S600F?
The MCN-S600F is an AC-powered compressor nebulizer for delivering prescribed aerosol treatments to adults in the home.
Is this nebulizer intended for home use?
Yes. The FDA-cleared use is in the patient's home, on the order of a physician.
Is the MCN-S600F intended for children?
The FDA-cleared indication for this device is adult home care. darevona Health does not market this product for pediatric use.
Does it require batteries?
No. The MCN-S600F runs on AC 120V / 60Hz power and must be plugged into a power outlet.
What is the nebulization rate?
The specified average nebulization rate is ≥0.2 mL/min.
How loud is the nebulizer?
The specified noise level is below 65 dBA.
What medication can I use?
Use only medication prescribed or recommended by your physician or pharmacist, and follow all medication and product instructions. Apart from medication, use only distilled water or saline solution. Essential oils, cough medicines and other viscous liquids are not suitable. darevona Health does not provide medication or dosage recommendations.
How much liquid can the cup hold?
The medication cup holds a maximum of 8 mL. Do not fill above the maximum mark.
How often should the device be cleaned?
Clean and disinfect the nebulizer kit before first use and clean it after each use, following the Instruction Manual. Let all parts dry completely before storing.
How often should I change the air filter?
Replace the air filter at least every 30 days, or sooner if it is dirty, wet or blocked. Do not clean and reuse a used filter. Use only original filters.
What comes with the nebulizer?
The package includes the compressor unit, medication cup, air tube, adult mask, mouthpiece, air filters, power cord and Instruction Manual.
How long does shipping take?
Orders normally arrive within 2–5 business days after fulfillment.
Is this product FDA approved?
The MCN-S600F is FDA 510(k) cleared under K123030. FDA clears devices through the 510(k) process; clearance is not the same as FDA approval. See Regulatory Information above for details.
What is the return period?
Eligible products can be returned within 30 days of delivery under the darevona Health return policy.
Reliable Home Care, Without the Complication
Straightforward compressor performance, U.S. fulfillment, and clear product support from darevona Health.
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