Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART

K-Number: K181524 · 2018-11-30

ApplicantVyaire Medical, Inc.
Decision Date2018-11-30
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART is a medical device manufactured by Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2018-11-30 under approval number K181524. 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 ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART?

Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART is a medical device that received FDA 510(k) clearance on 2018-11-30. It is manufactured by Vyaire Medical, Inc.. The 510(k) number is K181524.

When was Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART approved by the FDA?

Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART received FDA 510(k) clearance on 2018-11-30, under approval number K181524.

What company makes Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART?

Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART is manufactured by Vyaire Medical, Inc..

What is the FDA product code for Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART?

The FDA product code for Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART is BZC.

Other Devices by Vyaire Medical, Inc.

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 K190853Vyntus BODY K200510Multi-LinkTM X2 ECG Adapter and Leadwires K201082LTV2 Series Ventilators K211294Multi-Link X2 ECG Cable and Leadwire System

View all 9 devices →

Related Devices (Code: BZC)

K161295MiniBox +Pulmone Advanced Medical Devices, Ltd. K162515COSMED K5 Wearable Metabolic TechnologyCosmed Srl K183567Vyntus/SentrySuite Product LineVyaire Medical K190853Vyntus BODYVyaire Medical, Inc. 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.

↑