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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, continuous, facility use
510(k) Number K121379
Models NIC FM CPAP, NIP FM CPAP
Device Name PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY
Original Applicant
AIRON CORPORATION
751 north dr ste 6
melbourne,  FL  32934
Original Contact g. eric gjerde
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/08/2012
Decision Date 10/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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