FDA 510(k)

Monitor de Presión Arterial de Brazo (modelo: BPM-A7VL)

N.º K: K243118 · 2024-11-26

SolicitanteShenzhen Imdk Medical Technology Co., Ltd.

Fecha de decisión2024-11-26

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Arm Blood Pressure Monitor (model: BPM-A7VL) 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 2024-11-26 under 510(k) number K243118. 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 (model: BPM-A7VL)?

Arm Blood Pressure Monitor (model: BPM-A7VL) is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K243118.

When did Arm Blood Pressure Monitor (model: BPM-A7VL) receive FDA 510(k) clearance?

Arm Blood Pressure Monitor (model: BPM-A7VL) received FDA 510(k) clearance on 2024-11-26, under 510(k) number K243118.

Who is the listed applicant for Arm Blood Pressure Monitor (model: BPM-A7VL)?

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 Arm Blood Pressure Monitor (model: BPM-A7VL)?

The FDA product code for Arm Blood Pressure Monitor (model: BPM-A7VL) is DXN.

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Fuente oficial

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