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FDA 510(k)

Vyntus BODY

K-Number: K190853 · 2019-08-16

ApplicantVyaire Medical, Inc.
Decision Date2019-08-16
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Vyntus BODY is a medical device manufactured by Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2019-08-16 under approval number K190853. 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 Vyntus BODY?

Vyntus BODY is a medical device that received FDA 510(k) clearance on 2019-08-16. It is manufactured by Vyaire Medical, Inc.. The 510(k) number is K190853.

When was Vyntus BODY approved by the FDA?

Vyntus BODY received FDA 510(k) clearance on 2019-08-16, under approval number K190853.

What company makes Vyntus BODY?

Vyntus BODY is manufactured by Vyaire Medical, Inc..

What is the FDA product code for Vyntus BODY?

The FDA product code for Vyntus BODY is BZC.

Other Devices by Vyaire Medical, Inc.

K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART K171678Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable K191273Multi-Link X2 ECG and SpO2 Adapter K200510Multi-LinkTM X2 ECG Adapter and Leadwires K201082LTV2 Series Ventilators K211294Multi-Link X2 ECG Cable and Leadwire System

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Related Devices (Code: BZC)

K161295MiniBox +Pulmone Advanced Medical Devices, Ltd. K162515COSMED K5 Wearable Metabolic TechnologyCosmed Srl K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTVyaire Medical, Inc. K183567Vyntus/SentrySuite Product LineVyaire Medical K240293STSTechbopulm, 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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