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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 K053498
Device Name HYPEROX 101
Applicant
Wjo, Inc.
424 Mill St. At Canal'S End
Plz.
Bristol,  PA  19007
Applicant Contact CHRIS BELLETIERI
Correspondent
Wjo, Inc.
424 Mill St. At Canal'S End
Plz.
Bristol,  PA  19007
Correspondent Contact CHRIS BELLETIERI
Regulation Number868.5470
Classification Product Code
CBF  
Date Received12/16/2005
Decision Date 03/15/2006
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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