FDA 510(k)

ACE Cannula

N.º K: K242741 · 2025-01-08

SolicitanteAce Medical Industry Co., Ltd.

Fecha de decisión2025-01-08

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

ACE Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Ace Medical Industry Co., Ltd.. It received FDA 510(k) clearance on 2025-01-08 under 510(k) number K242741. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ACE Cannula?

ACE Cannula is a medical device that received FDA 510(k) clearance on 2025-01-08. The listed applicant is Ace Medical Industry Co., Ltd.. The 510(k) number is K242741.

When did ACE Cannula receive FDA 510(k) clearance?

ACE Cannula received FDA 510(k) clearance on 2025-01-08, under 510(k) number K242741.

Who is the listed applicant for ACE Cannula?

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

What is the FDA product code for ACE Cannula?

The FDA product code for ACE Cannula is FMI.

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Fuente oficial

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