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FDA 510(k)

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

K-Number: K190800 · 2020-02-06

ApplicantCosmed Srl
Decision Date2020-02-06
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors is the device name listed in this FDA 510(k) record. The listed applicant is Cosmed Srl. It received FDA 510(k) clearance on 2020-02-06 under 510(k) 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. The listed applicant is Cosmed Srl. The 510(k) number is K190800.

When did Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors receive FDA 510(k) clearance?

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

Who is the listed applicant for Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors?

The FDA 510(k) record lists Cosmed Srl as the applicant. This does not by itself establish the device manufacturer.

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 records listing Cosmed Srl as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162515COSMED K5 Wearable Metabolic Technology

Related Devices (Code: BTY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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