FDA 510(k)

Arm Electronic Sphygmomanometer

Número K: K193387 · 2021-01-27

RequerenteShenzhen Changkun Technology Co., Ltd.

Data da decisão2021-01-27

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Arm 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 K193387. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Arm Electronic Sphygmomanometer?

Arm 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 K193387.

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

Arm Electronic Sphygmomanometer received FDA 510(k) clearance on 2021-01-27, under 510(k) number K193387.

Who is the listed applicant for Arm 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 Arm Electronic Sphygmomanometer?

The FDA product code for Arm Electronic Sphygmomanometer is DXN.

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