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FDA 510(k)

COSMED K5 Wearable Metabolic Technology

K-Number: K162515 · 2017-06-20

ApplicantCosmed Srl
Decision Date2017-06-20
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COSMED K5 Wearable Metabolic Technology is a medical device manufactured by Cosmed Srl. It received FDA 510(k) clearance on 2017-06-20 under approval number K162515. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSMED K5 Wearable Metabolic Technology?

COSMED K5 Wearable Metabolic Technology is a medical device that received FDA 510(k) clearance on 2017-06-20. It is manufactured by Cosmed Srl. The 510(k) number is K162515.

When was COSMED K5 Wearable Metabolic Technology approved by the FDA?

COSMED K5 Wearable Metabolic Technology received FDA 510(k) clearance on 2017-06-20, under approval number K162515.

What company makes COSMED K5 Wearable Metabolic Technology?

COSMED K5 Wearable Metabolic Technology is manufactured by Cosmed Srl.

What is the FDA product code for COSMED K5 Wearable Metabolic Technology?

The FDA product code for COSMED K5 Wearable Metabolic Technology is BZC.

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Other Devices by Cosmed Srl

K190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors

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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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