FDA 510(k)

XR90 (XR90-SYS)

N.º K: K223125 · 2023-07-13

Fecha de decisión2023-07-13

Código de productoLLZ

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

XR90 (XR90-SYS) is the device name listed in this FDA 510(k) record. The listed applicant is Mediview Xr, Inc.. It received FDA 510(k) clearance on 2023-07-13 under 510(k) number K223125. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the XR90 (XR90-SYS)?

XR90 (XR90-SYS) is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Mediview Xr, Inc.. The 510(k) number is K223125.

When did XR90 (XR90-SYS) receive FDA 510(k) clearance?

XR90 (XR90-SYS) received FDA 510(k) clearance on 2023-07-13, under 510(k) number K223125.

Who is the listed applicant for XR90 (XR90-SYS)?

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

What is the FDA product code for XR90 (XR90-SYS)?

The FDA product code for XR90 (XR90-SYS) is LLZ.

Dispositivos relacionados (Código: LLZ)

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Fuente oficial

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