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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 K152223
Device Name Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
Applicant
Oxyheal Medical Systems, Inc.
3224 Hoover Ave.
National City,  CA  91950
Applicant Contact Edward J Chomas
Correspondent
Oxyheal Medical Systems, Inc.
3224 Hoover Ave.
National City,  CA  91950
Correspondent Contact Edward J Chomas
Regulation Number868.5470
Classification Product Code
CBF  
Date Received08/07/2015
Decision Date 04/29/2016
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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