FDA 510(k)

Automatic Arm Electronic Blood Pressure Monitor

Número K: K210435 · 2021-05-12

RequerenteShenzhen Lepu Intelligent Medical Equipment Co., Ltd.

Data da decisão2021-05-12

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Automatic Arm Electronic Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-05-12 under 510(k) number K210435. 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 Automatic Arm Electronic Blood Pressure Monitor?

Automatic Arm Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2021-05-12. The listed applicant is Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. The 510(k) number is K210435.

When did Automatic Arm Electronic Blood Pressure Monitor receive FDA 510(k) clearance?

Automatic Arm Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2021-05-12, under 510(k) number K210435.

Who is the listed applicant for Automatic Arm Electronic Blood Pressure Monitor?

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

What is the FDA product code for Automatic Arm Electronic Blood Pressure Monitor?

The FDA product code for Automatic Arm Electronic Blood Pressure Monitor is DXN.

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Fonte oficial

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