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FDA 510(k)

ECG Acquisition Systems

N.º K: K163607 · 2017-12-15

SolicitanteVales & Hills Biomedical Tech. , Ltd.
Fecha de decisión2017-12-15
Código de productoDPS
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

ECG Acquisition Systems is the device name listed in this FDA 510(k) record. The listed applicant is Vales & Hills Biomedical Tech. , Ltd.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K163607. 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 ECG Acquisition Systems?

ECG Acquisition Systems is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Vales & Hills Biomedical Tech. , Ltd.. The 510(k) number is K163607.

When did ECG Acquisition Systems receive FDA 510(k) clearance?

ECG Acquisition Systems received FDA 510(k) clearance on 2017-12-15, under 510(k) number K163607.

Who is the listed applicant for ECG Acquisition Systems?

The FDA 510(k) record lists Vales & Hills Biomedical Tech. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG Acquisition Systems?

The FDA product code for ECG Acquisition Systems is DPS.

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Dispositivos relacionados (Código: DPS)

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Fuente oficial

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