FDA 510(k)

Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107

N.º K: K210671 · 2021-08-13

SolicitanteWeony (Shenzhen) Technology Co., Ltd.

Fecha de decisión2021-08-13

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 is the device name listed in this FDA 510(k) record. The listed applicant is Weony (Shenzhen) Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K210671. 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 Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107?

Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Weony (Shenzhen) Technology Co., Ltd.. The 510(k) number is K210671.

When did Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 receive FDA 510(k) clearance?

Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 received FDA 510(k) clearance on 2021-08-13, under 510(k) number K210671.

Who is the listed applicant for Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107?

The FDA 510(k) record lists Weony (Shenzhen) Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107?

The FDA product code for Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 is DXN.

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Otros registros que enlistan a Weony (Shenzhen) Technology Co., Ltd. como solicitante

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Fuente oficial

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