FDA 510(k)

Foresight Intracardiac Echocardiology (ICE) System

Número K: K162789 · 2017-03-28

Data da decisão2017-03-28

Código do produtoDQO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Foresight Intracardiac Echocardiology (ICE) System is the device name listed in this FDA 510(k) record. The listed applicant is Conavi Medical, Inc.. It received FDA 510(k) clearance on 2017-03-28 under 510(k) number K162789. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Foresight Intracardiac Echocardiology (ICE) System?

Foresight Intracardiac Echocardiology (ICE) System is a medical device that received FDA 510(k) clearance on 2017-03-28. The listed applicant is Conavi Medical, Inc.. The 510(k) number is K162789.

When did Foresight Intracardiac Echocardiology (ICE) System receive FDA 510(k) clearance?

Foresight Intracardiac Echocardiology (ICE) System received FDA 510(k) clearance on 2017-03-28, under 510(k) number K162789.

Who is the listed applicant for Foresight Intracardiac Echocardiology (ICE) System?

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

What is the FDA product code for Foresight Intracardiac Echocardiology (ICE) System?

The FDA product code for Foresight Intracardiac Echocardiology (ICE) System is DQO.

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