FDA 510(k)

Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style

Número K: K181104 · 2018-08-29

RequerenteShenzhen Combei Technology Co., Ltd.

Data da decisão2018-08-29

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Combei Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-08-29 under 510(k) number K181104. 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 type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style?

Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style is a medical device that received FDA 510(k) clearance on 2018-08-29. The listed applicant is Shenzhen Combei Technology Co., Ltd.. The 510(k) number is K181104.

When did Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style receive FDA 510(k) clearance?

Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style received FDA 510(k) clearance on 2018-08-29, under 510(k) number K181104.

Who is the listed applicant for Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style?

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

What is the FDA product code for Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style?

The FDA product code for Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style is DXN.

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Outros registros que listam Shenzhen Combei Technology Co., Ltd. como candidato(a)

K202741Infrared Forehead Thermometer K171833Digital Blood Pressure Monitor-Wrist Style K163606Digital Blood Pressure Monitor-Automatic Upper Arm Style

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.

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