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FDA 510(k)

Bluetooth blood pressure monitor

N.º K: K171668 · 2018-02-26

SolicitanteVisiomed Group SA
Fecha de decisión2018-02-26
Código de productoDXN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Bluetooth blood pressure monitor is the device name listed in this FDA 510(k) record. The listed applicant is Visiomed Group SA. It received FDA 510(k) clearance on 2018-02-26 under 510(k) number K171668. 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 Bluetooth blood pressure monitor?

Bluetooth blood pressure monitor is a medical device that received FDA 510(k) clearance on 2018-02-26. The listed applicant is Visiomed Group SA. The 510(k) number is K171668.

When did Bluetooth blood pressure monitor receive FDA 510(k) clearance?

Bluetooth blood pressure monitor received FDA 510(k) clearance on 2018-02-26, under 510(k) number K171668.

Who is the listed applicant for Bluetooth blood pressure monitor?

The FDA 510(k) record lists Visiomed Group SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bluetooth blood pressure monitor?

The FDA product code for Bluetooth 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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