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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 K984313
Device Name HTU3
Applicant
HYOX SYSTEMS LTD.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004 -1109
Applicant Contact HOWARD M HOLSTEIN
Correspondent
HYOX SYSTEMS LTD.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004 -1109
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number868.5470
Classification Product Code
CBF  
Date Received12/02/1998
Decision Date 10/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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