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FDA 510(k)

Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)

Número K: K241613 · 2024-10-16

RequerenteShenzhen Hbcare Technology Co.,Ltd
Data da decisão2024-10-16
Código do produtoDXN
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Hbcare Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-10-16 under 510(k) number K241613. 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 Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)?

Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) is a medical device that received FDA 510(k) clearance on 2024-10-16. The listed applicant is Shenzhen Hbcare Technology Co.,Ltd. The 510(k) number is K241613.

When did Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) receive FDA 510(k) clearance?

Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) received FDA 510(k) clearance on 2024-10-16, under 510(k) number K241613.

Who is the listed applicant for Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)?

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

What is the FDA product code for Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)?

The FDA product code for Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) is DXN.

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Dispositivos Relacionados (Código: DXN)

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Fonte oficial

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