FDA 510(k)

Monitor de Presión Arterial de Tipo Brazo, Monitor Digital de Presión Arterial-Armónimo de Brazo Superior

N.º K: K181104 · 2018-08-29

SolicitanteShenzhen Combei Technology Co., Ltd.

Fecha de decisión2018-08-29

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Shenzhen Combei Technology Co., Ltd. como solicitante

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.

Fuente oficial

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