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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 N. Dr. Suite 6
Melbourne,  FL  32934
Applicant Contact G. ERIC GJERDE
Correspondent
Airon Corporation
751 N. Dr. Suite 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
Predetermined Change
Control Plan Authorized		 No
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