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FDA 510(k)

HRVWatch-Mini Wrist Monitor

N.º K: K201914 · 2021-06-07

SolicitanteTaiwan Scientific Corporation
Fecha de decisión2021-06-07
Código de productoDXN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

HRVWatch-Mini Wrist Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Scientific Corporation. It received FDA 510(k) clearance on 2021-06-07 under 510(k) number K201914. 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 HRVWatch-Mini Wrist Monitor?

HRVWatch-Mini Wrist Monitor is a medical device that received FDA 510(k) clearance on 2021-06-07. The listed applicant is Taiwan Scientific Corporation. The 510(k) number is K201914.

When did HRVWatch-Mini Wrist Monitor receive FDA 510(k) clearance?

HRVWatch-Mini Wrist Monitor received FDA 510(k) clearance on 2021-06-07, under 510(k) number K201914.

Who is the listed applicant for HRVWatch-Mini Wrist Monitor?

The FDA 510(k) record lists Taiwan Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HRVWatch-Mini Wrist Monitor?

The FDA product code for HRVWatch-Mini Wrist Monitor is DXN.

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Dispositivos relacionados (Código: DXN)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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