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Vyaire Medical, Inc.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories5
Latest FDA decision2024-11-12
TypeNumberDevice NameCodeDateActions
510(k) K230915 AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen MaskCCK2024-11-12 View
510(k) K231380 AirLife DuoTherm™ Humidification SystemBTT2023-08-10 View
510(k) K201082 LTV2 Series VentilatorsCBK2021-11-10 View
510(k) K211294 Multi-Link X2 ECG Cable and Leadwire SystemDSA2021-08-16 View
510(k) K200510 Multi-LinkTM X2 ECG Adapter and LeadwiresDSA2020-10-09 View
510(k) K191273 Multi-Link X2 ECG and SpO2 AdapterDSA2019-09-13 View
510(k) K190853 Vyntus BODYBZC2019-08-16 View
510(k) K181524 Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTBZC2018-11-30 View
510(k) K171678 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/20ft, 5/pkg, DisposableCCK2018-04-30 View
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