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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 K021605
Device Name MEDGEM
Applicant
Healthetech, Inc.
523 Park Point Dr.
Golden,  CO  80401
Applicant Contact GLENN M THIBAULT
Correspondent
Healthetech, Inc.
523 Park Point Dr.
Golden,  CO  80401
Correspondent Contact GLENN M THIBAULT
Regulation Number868.1730
Classification Product Code
BZL  
Date Received05/16/2002
Decision Date 06/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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