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FDA 510(k)

Automatic Digital Blood Pressure Monitor

N.º K: K210152 · 2021-09-23

SolicitanteAviche Shandong Medical Technology Co, Ltd.
Fecha de decisión2021-09-23
Código de productoDXN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Automatic Digital Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Aviche Shandong Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K210152. 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 Automatic Digital Blood Pressure Monitor?

Automatic Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Aviche Shandong Medical Technology Co, Ltd.. The 510(k) number is K210152.

When did Automatic Digital Blood Pressure Monitor receive FDA 510(k) clearance?

Automatic Digital Blood Pressure Monitor received FDA 510(k) clearance on 2021-09-23, under 510(k) number K210152.

Who is the listed applicant for Automatic Digital Blood Pressure Monitor?

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

What is the FDA product code for Automatic Digital Blood Pressure Monitor?

The FDA product code for Automatic Digital Blood Pressure Monitor is DXN.

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Dispositivos relacionados (Código: DXN)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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