FDA 510(k)

Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)

Número K: K251307 · 2026-01-12

RequerenteShenzhen Hingmed Medical Instrument Co., Ltd.

Data da decisão2026-01-12

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Hingmed Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-01-12 under 510(k) number K251307. 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 Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)?

Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) is a medical device that received FDA 510(k) clearance on 2026-01-12. The listed applicant is Shenzhen Hingmed Medical Instrument Co., Ltd.. The 510(k) number is K251307.

When did Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) receive FDA 510(k) clearance?

Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) received FDA 510(k) clearance on 2026-01-12, under 510(k) number K251307.

Who is the listed applicant for Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)?

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

What is the FDA product code for Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)?

The FDA product code for Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) is DXN.

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Outros registros que listam Shenzhen Hingmed Medical Instrument Co., Ltd. como candidato(a)

K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)K231984Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)

Dispositivos Relacionados (Código: DXN)

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

Fonte oficial

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