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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 K052866
Device Name OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER
Applicant
Oxyheal Health Group
3224 Hoover Ave.
National City,  CA  91950
Applicant Contact DAVE HEANY
Correspondent
Oxyheal Health Group
3224 Hoover Ave.
National City,  CA  91950
Correspondent Contact DAVE HEANY
Regulation Number868.5470
Classification Product Code
CBF  
Date Received10/11/2005
Decision Date 12/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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