FDA 510(k)

Creavo Vitalscan Magnetocardiograph

Número K: K170154 · 2017-10-12

RequerenteCreavo Medical Technologies, Ltd.

Data da decisão2017-10-12

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Creavo Vitalscan Magnetocardiograph is the device name listed in this FDA 510(k) record. The listed applicant is Creavo Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K170154. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Creavo Vitalscan Magnetocardiograph?

Creavo Vitalscan Magnetocardiograph is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Creavo Medical Technologies, Ltd.. The 510(k) number is K170154.

When did Creavo Vitalscan Magnetocardiograph receive FDA 510(k) clearance?

Creavo Vitalscan Magnetocardiograph received FDA 510(k) clearance on 2017-10-12, under 510(k) number K170154.

Who is the listed applicant for Creavo Vitalscan Magnetocardiograph?

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

What is the FDA product code for Creavo Vitalscan Magnetocardiograph?

The FDA product code for Creavo Vitalscan Magnetocardiograph is DPS.

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Fonte oficial

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