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FDA 510(k)

Korotkoff sound blood pressure monitor

N.º K: K253982 · 2026-04-21

SolicitanteBeijing Hanvon Health Technology Co., Ltd.
Fecha de decisión2026-04-21
Código de productoDXN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Korotkoff sound blood pressure monitor is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Hanvon Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-21 under 510(k) number K253982. 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 Korotkoff sound blood pressure monitor?

Korotkoff sound blood pressure monitor is a medical device that received FDA 510(k) clearance on 2026-04-21. The listed applicant is Beijing Hanvon Health Technology Co., Ltd.. The 510(k) number is K253982.

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

Korotkoff sound blood pressure monitor received FDA 510(k) clearance on 2026-04-21, under 510(k) number K253982.

Who is the listed applicant for Korotkoff sound blood pressure monitor?

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

What is the FDA product code for Korotkoff sound blood pressure monitor?

The FDA product code for Korotkoff sound 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.

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Fuente oficial

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