FDA 510(k)

Multi-LinkTM X2 ECG Adapter and Leadwires

Número K: K200510 · 2020-10-09

Data da decisão2020-10-09

Código do produtoDSA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Multi-LinkTM X2 ECG Adapter and Leadwires 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 2020-10-09 under 510(k) number K200510. 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-LinkTM X2 ECG Adapter and Leadwires?

Multi-LinkTM X2 ECG Adapter and Leadwires is a medical device that received FDA 510(k) clearance on 2020-10-09. The listed applicant is Vyaire Medical, Inc.. The 510(k) number is K200510.

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

Multi-LinkTM X2 ECG Adapter and Leadwires received FDA 510(k) clearance on 2020-10-09, under 510(k) number K200510.

Who is the listed applicant for Multi-LinkTM X2 ECG Adapter and Leadwires?

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-LinkTM X2 ECG Adapter and Leadwires?

The FDA product code for Multi-LinkTM X2 ECG Adapter and Leadwires is DSA.

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Fonte oficial

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