FDA 510(k)

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System

N.º K: K163316 · 2017-06-22

Fecha de decisión2017-06-22

Código de productoDSA

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 303, Inc.. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K163316. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System?

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Carefusion 303, Inc.. The 510(k) number is K163316.

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

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System received FDA 510(k) clearance on 2017-06-22, under 510(k) number K163316.

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

The FDA 510(k) record lists Carefusion 303, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System?

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

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