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FDA 510(k) Application Details - K021605
Device Classification Name
Computer, Oxygen-Uptake
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510(K) Number
K021605
Device Name
Computer, Oxygen-Uptake
Applicant
HEALTHETECH, INC.
523 PARK POINT DR.
GOLDEN, CO 80401 US
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Contact
GLENN M THIBAULT
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Regulation Number
868.1730
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Classification Product Code
BZL
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More FDA Info for this Product Code
Date Received
05/16/2002
Decision Date
06/14/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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