COSMED K5 Wearable Metabolic Technology— 510(k) K162515

Name: FDA 510(k) clearance K162515
Creator: U.S. Food and Drug Administration
Published: 2017-06-20

Substantially Equivalent

Cosmed Srl

FDA 510(k) clearance K162515 for COSMED K5 Wearable Metabolic Technology, Substantially Equivalent on 2017-06-20. Applicant: Cosmed Srl. Device class: 2.

Clearance details

Applicant: Cosmed Srl
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 2016-09-08
Decision date: 2017-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pavona Di Albano Rome, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZC

view all

K240293 — STS2024-09-17
K183567 — Vyntus/SentrySuite Product Line2019-08-23
K190853 — Vyntus BODY2019-08-16
K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART2018-11-30
K161295 — MiniBox +2016-10-21

More clearances from Cosmed Srl

view all

K190800 — Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors2020-02-06
K120146 — QUARK SERIES2012-12-11
K093174 — SPIROPALM2010-02-26
K071533 — FITMATE SERIES2007-09-28
K040549 — COSMED PONY FX2004-09-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.