FDA 510(k)

TRUDERMAL Pro (ZLD-390)

N.º K: K251012 · 2025-08-14

SolicitanteShenzhen Kaiyan Medical Equipment Co., Ltd.

Fecha de decisión2025-08-14

Código de productoOHS

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

TRUDERMAL Pro (ZLD-390) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-08-14 under 510(k) number K251012. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TRUDERMAL Pro (ZLD-390)?

TRUDERMAL Pro (ZLD-390) is a medical device that received FDA 510(k) clearance on 2025-08-14. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K251012.

When did TRUDERMAL Pro (ZLD-390) receive FDA 510(k) clearance?

TRUDERMAL Pro (ZLD-390) received FDA 510(k) clearance on 2025-08-14, under 510(k) number K251012.

Who is the listed applicant for TRUDERMAL Pro (ZLD-390)?

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

What is the FDA product code for TRUDERMAL Pro (ZLD-390)?

The FDA product code for TRUDERMAL Pro (ZLD-390) is OHS.

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Fuente oficial

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