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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Hyperbaric
510(k) Number K011592
Device Name OXYGEN TREATMENT HOOD
Applicant
Amron International Diving Supply, Inc.
759 W. Fourth Ave.
Escondido,  CA  92025
Applicant Contact NORMA F OCKWIG
Correspondent
Amron International Diving Supply, Inc.
759 W. Fourth Ave.
Escondido,  CA  92025
Correspondent Contact NORMA F OCKWIG
Regulation Number868.5470
Classification Product Code
CBF  
Date Received05/24/2001
Decision Date 06/19/2002
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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