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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K080692
Device Name MACS CPAP SYSTEM
Applicant
Airon Corporation
129 W. Hibiscus Blvd., Suite S
Melbourne,  FL  32901
Applicant Contact ERIC GJERDE
Correspondent
Airon Corporation
129 W. Hibiscus Blvd., Suite S
Melbourne,  FL  32901
Correspondent Contact ERIC GJERDE
Regulation Number868.5925
Classification Product Code
BTL  
Subsequent Product Code
BYE  
Date Received03/11/2008
Decision Date 06/20/2008
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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