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510(k) K093080

METAPHOR METABOLIC MONITOR by Treymed, Inc. — Product Code BZL

K093080 is an FDA 510(k) premarket notification submitted by Treymed, Inc. for the device "METAPHOR METABOLIC MONITOR". The FDA issued a decision of Substantially Equivalent on January 22, 2010. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2010
Date Received
September 30, 2009
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

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  • K110810 — ANASCIENT BREATH MONITOR (June 21, 2011)
  • 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)
  • K010577 — BODYGEM, MODEL HB211 (January 10, 2002)
  • K954731 — OXYLOG 2 (January 6, 1997)

FDA data resources