FDA 510(k)

F3

N.º K: K222998 · 2023-06-20

Fecha de decisión2023-06-20

Código de productoOWB

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

F3 is the device name listed in this FDA 510(k) record. The listed applicant is Acrew Imaging, Inc.. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K222998. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the F3?

F3 is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Acrew Imaging, Inc.. The 510(k) number is K222998.

When did F3 receive FDA 510(k) clearance?

F3 received FDA 510(k) clearance on 2023-06-20, under 510(k) number K222998.

Who is the listed applicant for F3?

The FDA 510(k) record lists Acrew Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F3?

The FDA product code for F3 is OWB.

Dispositivos relacionados (Código: OWB)

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Fuente oficial

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