FDA 510(k)

Multi-Link X2 ECG Cable and Leadwire System

Número K: K211294 · 2021-08-16

Data da decisão2021-08-16

Código do produtoDSA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Multi-Link X2 ECG Cable and Leadwire System 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 2021-08-16 under 510(k) number K211294. 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 Cable and Leadwire System?

Multi-Link X2 ECG Cable and Leadwire System is a medical device that received FDA 510(k) clearance on 2021-08-16. The listed applicant is Vyaire Medical, Inc.. The 510(k) number is K211294.

When did Multi-Link X2 ECG Cable and Leadwire System receive FDA 510(k) clearance?

Multi-Link X2 ECG Cable and Leadwire System received FDA 510(k) clearance on 2021-08-16, under 510(k) number K211294.

Who is the listed applicant for Multi-Link X2 ECG Cable and Leadwire System?

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 Cable and Leadwire System?

The FDA product code for Multi-Link X2 ECG Cable and Leadwire System is DSA.

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