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510(k) K010577

BODYGEM, MODEL HB211 by Healthetech, Inc. — Product Code BZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2002
Date Received
February 27, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Oxygen-Uptake
Device Class
Class II
Regulation Number
868.1730
Review Panel
AN
Submission Type

Other clearances by Healthetech, Inc.

  • K021605 — MEDGEM (June 14, 2002)

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  • K093080 — METAPHOR METABOLIC MONITOR (January 22, 2010)
  • K071533 — FITMATE SERIES (September 28, 2007)
  • K070858 — EXPRESS SERIES (April 16, 2007)
  • K061731 — MEDGRAPHICS ULTIMA SYSTEM (September 6, 2006)
  • K021490 — REEVUE INDIRECT CALORIMETER, MODEL#8100 (January 2, 2003)
  • K021605 — MEDGEM (June 14, 2002)
  • K954731 — OXYLOG 2 (January 6, 1997)