FDA 510(k)

CardiMax Electrocardiograph

N.º K: K173226 · 2018-04-16

Fecha de decisión2018-04-16

Código de productoDPS

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

CardiMax Electrocardiograph is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 2018-04-16 under 510(k) number K173226. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CardiMax Electrocardiograph?

CardiMax Electrocardiograph is a medical device that received FDA 510(k) clearance on 2018-04-16. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K173226.

When did CardiMax Electrocardiograph receive FDA 510(k) clearance?

CardiMax Electrocardiograph received FDA 510(k) clearance on 2018-04-16, under 510(k) number K173226.

Who is the listed applicant for CardiMax Electrocardiograph?

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

What is the FDA product code for CardiMax Electrocardiograph?

The FDA product code for CardiMax Electrocardiograph is DPS.

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Fuente oficial

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