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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
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