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510(k) K162515

COSMED K5 Wearable Metabolic Technology by Cosmed Srl — Product Code BZC

K162515 is an FDA 510(k) premarket notification submitted by Cosmed Srl for the device "COSMED K5 Wearable Metabolic Technology". The FDA issued a decision of Substantially Equivalent on June 20, 2017. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Cosmed Srl has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2017
Date Received
September 8, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Data
Device Class
Class II
Regulation Number
868.1880
Review Panel
AN
Submission Type

Other clearances by Cosmed Srl

  • K190800 — Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors (February 6, 2020)
  • K120146 — QUARK SERIES (December 11, 2012)
  • K093174 — SPIROPALM (February 26, 2010)
  • K071533 — FITMATE SERIES (September 28, 2007)
  • 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 BZC

  • K240293 — STS (September 17, 2024)
  • K183567 — Vyntus/SentrySuite Product Line (August 23, 2019)
  • K190853 — Vyntus BODY (August 16, 2019)
  • K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable (November 30, 2018)
  • K161295 — MiniBox + (October 21, 2016)
  • K150810 — Vyntus / SentrySuite Product Line (August 14, 2015)
  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K133051 — PULMONE MINIBOX PFT TM (May 2, 2014)
  • K102047 — LCI OPTION FOR INNOCOR (November 1, 2011)
  • K072323 — MASTERSCREEN & OXYCON CPX (October 10, 2007)

FDA data resources