FDA 510(k)

Multi-Link X2 ECG and SpO2 Adapter

Número K: K191273 · 2019-09-13

Data da decisão2019-09-13

Código do produtoDSA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Multi-Link X2 ECG and SpO2 Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K191273. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Multi-Link X2 ECG and SpO2 Adapter?

Multi-Link X2 ECG and SpO2 Adapter is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Vyaire Medical, Inc.. The 510(k) number is K191273.

When did Multi-Link X2 ECG and SpO2 Adapter receive FDA 510(k) clearance?

Multi-Link X2 ECG and SpO2 Adapter received FDA 510(k) clearance on 2019-09-13, under 510(k) number K191273.

Who is the listed applicant for Multi-Link X2 ECG and SpO2 Adapter?

The FDA 510(k) record lists Vyaire Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multi-Link X2 ECG and SpO2 Adapter?

The FDA product code for Multi-Link X2 ECG and SpO2 Adapter is DSA.

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