FDA 510(k)

Monitor de Presión Arterial de brazo/Monitor de Presión Arterial Inalámbrico Inteligente Automático

N.º K: K222887 · 2023-04-10

SolicitanteFamidoc Technology Company Limited

Fecha de decisión2023-04-10

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Famidoc Technology Company Limited. It received FDA 510(k) clearance on 2023-04-10 under 510(k) number K222887. 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 Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor?

Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2023-04-10. The listed applicant is Famidoc Technology Company Limited. The 510(k) number is K222887.

When did Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor receive FDA 510(k) clearance?

Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor received FDA 510(k) clearance on 2023-04-10, under 510(k) number K222887.

Who is the listed applicant for Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor?

The FDA 510(k) record lists Famidoc Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor?

The FDA product code for Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor is DXN.

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Otros registros que enlistan a Famidoc Technology Company Limited como solicitante

K233192Wireless Smart Thermometer K191673Upper Arm Blood Pressure Monitor

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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