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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 the device name listed in this FDA 510(k) record. The listed applicant is Cosmed Srl. It received FDA 510(k) clearance on 2017-06-20 under 510(k) 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. The listed applicant is Cosmed Srl. The 510(k) number is K162515.

When did COSMED K5 Wearable Metabolic Technology receive FDA 510(k) clearance?

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

Who is the listed applicant for COSMED K5 Wearable Metabolic Technology?

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 K5 Wearable Metabolic Technology?

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

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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.

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

Related Devices (Code: BZC)

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.

K240293STSTechbopulm, Ltd.K183567Vyntus/SentrySuite Product LineVyaire MedicalK190853Vyntus BODYVyaire Medical, Inc.K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTVyaire Medical, Inc.K161295MiniBox +Pulmone Advanced Medical Devices, 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.

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