FDA 510(k)

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

K-Number: K190800 · 2020-02-06

Decision Date2020-02-06

Product CodeBTY

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors is a medical device manufactured by Cosmed Srl. It received FDA 510(k) clearance on 2020-02-06 under approval number K190800. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors?

Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors is a medical device that received FDA 510(k) clearance on 2020-02-06. It is manufactured by Cosmed Srl. The 510(k) number is K190800.

When was Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors approved by the FDA?

Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors received FDA 510(k) clearance on 2020-02-06, under approval number K190800.

What company makes Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors?

Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors is manufactured by Cosmed Srl.

What is the FDA product code for Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors?

The FDA product code for Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors is BTY.

Other Devices by Cosmed Srl

K162515COSMED K5 Wearable Metabolic Technology

Related Devices (Code: BTY)

K150888Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc. K161534EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG K181912Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation K173937SpiroSphereEresearchtechnology GmbH K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH K221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.