FDA 510(k)

Monitor de Presión Arterial de Muñeca Microlife Modelo BP3GK1-4B

N.º K: K211288 · 2021-11-04

SolicitanteMicrolife Intellectual Property GmbH

Fecha de decisión2021-11-04

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2021-11-04 under 510(k) number K211288. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B?

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K211288.

When did Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B receive FDA 510(k) clearance?

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B received FDA 510(k) clearance on 2021-11-04, under 510(k) number K211288.

Who is the listed applicant for Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B?

The FDA 510(k) record lists Microlife Intellectual Property GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B?

The FDA product code for Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B is DXN.

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Fuente oficial

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