FDA 510(k)

Wrist Electronic Sphygmomanometer

N.º K: K193386 · 2021-01-27

SolicitanteShenzhen Changkun Technology Co., Ltd.

Fecha de decisión2021-01-27

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Wrist Electronic Sphygmomanometer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-01-27 under 510(k) number K193386. 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 Wrist Electronic Sphygmomanometer?

Wrist Electronic Sphygmomanometer is a medical device that received FDA 510(k) clearance on 2021-01-27. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K193386.

When did Wrist Electronic Sphygmomanometer receive FDA 510(k) clearance?

Wrist Electronic Sphygmomanometer received FDA 510(k) clearance on 2021-01-27, under 510(k) number K193386.

Who is the listed applicant for Wrist Electronic Sphygmomanometer?

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

What is the FDA product code for Wrist Electronic Sphygmomanometer?

The FDA product code for Wrist Electronic Sphygmomanometer is DXN.

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Fuente oficial

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