FDA 510(k)

HFT750U

N.º K: K242931 · 2025-05-15

Fecha de decisión2025-05-15

Código de productoMNT

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

HFT750U is the device name listed in this FDA 510(k) record. The listed applicant is Mekics Co., Ltd.. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K242931. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HFT750U?

HFT750U is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is Mekics Co., Ltd.. The 510(k) number is K242931.

When did HFT750U receive FDA 510(k) clearance?

HFT750U received FDA 510(k) clearance on 2025-05-15, under 510(k) number K242931.

Who is the listed applicant for HFT750U?

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

What is the FDA product code for HFT750U?

The FDA product code for HFT750U is MNT.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.