FDA 510(k)

MPXA-2000

N.º K: K222036 · 2023-03-22

Fecha de decisión2023-03-22

Código de productoQIH

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

MPXA-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Medipixel, Inc.. It received FDA 510(k) clearance on 2023-03-22 under 510(k) number K222036. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MPXA-2000?

MPXA-2000 is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Medipixel, Inc.. The 510(k) number is K222036.

When did MPXA-2000 receive FDA 510(k) clearance?

MPXA-2000 received FDA 510(k) clearance on 2023-03-22, under 510(k) number K222036.

Who is the listed applicant for MPXA-2000?

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

What is the FDA product code for MPXA-2000?

The FDA product code for MPXA-2000 is QIH.

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Fuente oficial

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