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510(k) K021605

MEDGEM by Healthetech, Inc. — Product Code BZL

K021605 is an FDA 510(k) premarket notification submitted by Healthetech, Inc. for the device "MEDGEM". The FDA issued a decision of Substantially Equivalent on June 14, 2002. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Healthetech, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2002
Date Received
May 16, 2002
Clearance Type
Special
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.

  • K010577 — BODYGEM, MODEL HB211 (January 10, 2002)

Other clearances for product code BZL

  • K200076 — Breezing Med (September 25, 2020)
  • K190561 — NICU V'02 (September 4, 2020)
  • K110810 — ANASCIENT BREATH MONITOR (June 21, 2011)
  • 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)
  • K010577 — BODYGEM, MODEL HB211 (January 10, 2002)
  • K954731 — OXYLOG 2 (January 6, 1997)

FDA data resources