Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors— 510(k) K190800

Name: FDA 510(k) clearance K190800
Creator: U.S. Food and Drug Administration
Published: 2020-02-06

Substantially Equivalent

Cosmed Srl

FDA 510(k) clearance K190800 for Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors, Substantially Equivalent on 2020-02-06. Applicant: Cosmed Srl. Device class: 2.

Clearance details

Applicant: Cosmed Srl
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2019-03-28
Decision date: 2020-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rome, IT

Download summary PDF View on FDA.gov ↗

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