FDA 510(k)

CardioInsight Cardiac Mapping System

N.º K: K162440 · 2016-11-04

SolicitanteCardioinsight Technologies, Inc.

Fecha de decisión2016-11-04

Código de productoDQK

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

CardioInsight Cardiac Mapping System is the device name listed in this FDA 510(k) record. The listed applicant is Cardioinsight Technologies, Inc.. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K162440. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CardioInsight Cardiac Mapping System?

CardioInsight Cardiac Mapping System is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Cardioinsight Technologies, Inc.. The 510(k) number is K162440.

When did CardioInsight Cardiac Mapping System receive FDA 510(k) clearance?

CardioInsight Cardiac Mapping System received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162440.

Who is the listed applicant for CardioInsight Cardiac Mapping System?

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

What is the FDA product code for CardioInsight Cardiac Mapping System?

The FDA product code for CardioInsight Cardiac Mapping System is DQK.

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Fuente oficial

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