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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Oxygen-Uptake
510(k) Number K010577
Device Name BODYGEM, MODEL HB211
Applicant
Healthetech, Inc.
325 Los Gatos-Saratoga Rd.
Los Gatos,  CA  95070
Applicant Contact NOEL L JOHNSON
Correspondent
Healthetech, Inc.
325 Los Gatos-Saratoga Rd.
Los Gatos,  CA  95070
Correspondent Contact NOEL L JOHNSON
Regulation Number868.1730
Classification Product Code
BZL  
Date Received02/27/2001
Decision Date 01/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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