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510(k) K071533

FITMATE SERIES by Cosmed Srl — Product Code BZL

K071533 is an FDA 510(k) premarket notification submitted by Cosmed Srl for the device "FITMATE SERIES". The FDA issued a decision of Substantially Equivalent on September 28, 2007. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Cosmed Srl has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2007
Date Received
June 5, 2007
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 Cosmed Srl

  • K190800 — Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors (February 6, 2020)
  • K162515 — COSMED K5 Wearable Metabolic Technology (June 20, 2017)
  • K120146 — QUARK SERIES (December 11, 2012)
  • K093174 — SPIROPALM (February 26, 2010)
  • K040549 — COSMED PONY FX (September 28, 2004)
  • K020745 — COSMED MICROQUARK (January 2, 2003)
  • K014262 — COSMED QUARK C12/QUARK T12 (March 26, 2002)
  • K001174 — COSMED QUARK (January 11, 2001)
  • K963373 — COSMED K4 (September 10, 1997)

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)
  • 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