FDA 510(k)

Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)

Número K: K251143 · 2025-12-19

RequerenteNingbo Ranor Medical Science & Technology Co., Ltd.

Data da decisão2025-12-19

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Ranor Medical Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K251143. 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 Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)?

Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Ningbo Ranor Medical Science & Technology Co., Ltd.. The 510(k) number is K251143.

When did Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) receive FDA 510(k) clearance?

Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) received FDA 510(k) clearance on 2025-12-19, under 510(k) number K251143.

Who is the listed applicant for Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)?

The FDA 510(k) record lists Ningbo Ranor Medical Science & Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)?

The FDA product code for Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) is DXN.

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Outros registros que listam Ningbo Ranor Medical Science & Technology Co., Ltd. como candidato(a)

K193456Arm Blood Pressure Monitor K200578Infrared Thermometer Model Number RN-50A,RN-50B K200471Infrared Thermometer Model Number RN-60A,RN-60B

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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