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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
Device Name PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY
Applicant
AIRON CORPORATION
751 North Dr Ste 6
Melbourne,  FL  32934
Applicant Contact G. ERIC GJERDE
Correspondent
AIRON CORPORATION
751 North Dr Ste 6
Melbourne,  FL  32934
Correspondent Contact G. ERIC GJERDE
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/08/2012
Decision Date 10/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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