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FDA 510(k)

Superflow Prime Treatment System (ASP-1M)

N.º K: K242286 · 2024-11-08

SolicitanteGuangzhou Aimira Innovation Technology Co, Ltd.
Fecha de decisión2024-11-08
Código de productoGEI
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Superflow Prime Treatment System (ASP-1M) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Aimira Innovation Technology Co, Ltd.. It received FDA 510(k) clearance on 2024-11-08 under 510(k) number K242286. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Superflow Prime Treatment System (ASP-1M)?

Superflow Prime Treatment System (ASP-1M) is a medical device that received FDA 510(k) clearance on 2024-11-08. The listed applicant is Guangzhou Aimira Innovation Technology Co, Ltd.. The 510(k) number is K242286.

When did Superflow Prime Treatment System (ASP-1M) receive FDA 510(k) clearance?

Superflow Prime Treatment System (ASP-1M) received FDA 510(k) clearance on 2024-11-08, under 510(k) number K242286.

Who is the listed applicant for Superflow Prime Treatment System (ASP-1M)?

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

What is the FDA product code for Superflow Prime Treatment System (ASP-1M)?

The FDA product code for Superflow Prime Treatment System (ASP-1M) is GEI.

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Fuente oficial

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

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