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FDA 510(k)

G0 Blood Pressure Monitoring System (G0)

N.º K: K250415 · 2025-07-02

SolicitanteAktiia SA
Fecha de decisión2025-07-02
Código de productoDXN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

G0 Blood Pressure Monitoring System (G0) is the device name listed in this FDA 510(k) record. The listed applicant is Aktiia SA. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250415. 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 G0 Blood Pressure Monitoring System (G0)?

G0 Blood Pressure Monitoring System (G0) is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Aktiia SA. The 510(k) number is K250415.

When did G0 Blood Pressure Monitoring System (G0) receive FDA 510(k) clearance?

G0 Blood Pressure Monitoring System (G0) received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250415.

Who is the listed applicant for G0 Blood Pressure Monitoring System (G0)?

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

What is the FDA product code for G0 Blood Pressure Monitoring System (G0)?

The FDA product code for G0 Blood Pressure Monitoring System (G0) 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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