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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 K100268
Device Name SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
Applicant
Sechrist Industries, Inc.
4225 E. La Palma Ave.
Anaheim,  CA  92807
Applicant Contact VICTOR ARELLANO
Correspondent
Sechrist Industries, Inc.
4225 E. La Palma Ave.
Anaheim,  CA  92807
Correspondent Contact VICTOR ARELLANO
Regulation Number868.5470
Classification Product Code
CBF  
Date Received01/29/2010
Decision Date 04/26/2010
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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