FDA 510(k) Applications Submitted by Vyaire Medical, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K181524 |
06/11/2018 |
Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART |
Vyaire Medical, Inc. |
| K211294 |
04/28/2021 |
Multi-Link X2 ECG Cable and Leadwire System |
Vyaire Medical, Inc. |
| K171678 |
06/06/2017 |
Gas 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 |
Vyaire Medical, Inc. |
| K231380 |
05/12/2023 |
AirLife DuoThermÖ Humidification System |
Vyaire Medical, Inc. |
| K200510 |
03/02/2020 |
Multi-LinkTM X2 ECG Adapter and Leadwires |
Vyaire Medical, Inc. |
| K191273 |
05/13/2019 |
Multi-Link X2 ECG and SpO2 Adapter |
Vyaire Medical, Inc. |
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