FDA 510(k)

Multi-Link X2 ECG Cable and Lead Wire System

Número K: K162432 · 2017-01-18

Data da decisão2017-01-18

Código do produtoDSA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Multi-Link X2 ECG Cable and Lead Wire System is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 2200, Inc.. It received FDA 510(k) clearance on 2017-01-18 under 510(k) number K162432. 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 Lead Wire System?

Multi-Link X2 ECG Cable and Lead Wire System is a medical device that received FDA 510(k) clearance on 2017-01-18. The listed applicant is Carefusion 2200, Inc.. The 510(k) number is K162432.

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

Multi-Link X2 ECG Cable and Lead Wire System received FDA 510(k) clearance on 2017-01-18, under 510(k) number K162432.

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

The FDA 510(k) record lists Carefusion 2200, 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 Lead Wire System?

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

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