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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 K043085
Device Name MODIFICATION TO: PNEUTON VENTILATOR
Applicant
Airon Corporation
17 E. Melbourne Ave.
Melbourne,  FL  32901
Applicant Contact ERIC GJERDE
Correspondent
Airon Corporation
17 E. Melbourne Ave.
Melbourne,  FL  32901
Correspondent Contact ERIC GJERDE
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/08/2004
Decision Date 12/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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