FDA 510(k)

Wrist Blood Pressure Monitor (BPM-W1VL)

N.º K: K253133 · 2026-02-13

SolicitanteShenzhen Imdk Medical Technology Co., Ltd.

Fecha de decisión2026-02-13

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Wrist Blood Pressure Monitor (BPM-W1VL) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K253133. 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 Wrist Blood Pressure Monitor (BPM-W1VL)?

Wrist Blood Pressure Monitor (BPM-W1VL) is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K253133.

When did Wrist Blood Pressure Monitor (BPM-W1VL) receive FDA 510(k) clearance?

Wrist Blood Pressure Monitor (BPM-W1VL) received FDA 510(k) clearance on 2026-02-13, under 510(k) number K253133.

Who is the listed applicant for Wrist Blood Pressure Monitor (BPM-W1VL)?

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

What is the FDA product code for Wrist Blood Pressure Monitor (BPM-W1VL)?

The FDA product code for Wrist Blood Pressure Monitor (BPM-W1VL) is DXN.

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Fuente oficial

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