Cleared Traditional

Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors

K190800 · Cosmed Srl · Anesthesiology
Feb 2020
Decision
315d
Days
Class 2
Risk

About This 510(k) Submission

K190800 is an FDA 510(k) clearance for the Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Cosmed Srl (Rome, IT). The FDA issued a Cleared decision on February 6, 2020, 315 days after receiving the submission on March 28, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K190800 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2019
Decision Date February 06, 2020
Days to Decision 315 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTY — Calculator, Predicted Values, Pulmonary Function
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890

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