FDA 510(k)

CAREMIBRAIN

K-Nummer: K232569 · 2023-09-21

AntragstellerGeneral Equipment For Medical Imaging, S.A.

Entscheidungsdatum2023-09-21

ProduktcodeKPS

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

CAREMIBRAIN is the device name listed in this FDA 510(k) record. The listed applicant is General Equipment For Medical Imaging, S.A.. It received FDA 510(k) clearance on 2023-09-21 under 510(k) number K232569. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the CAREMIBRAIN?

CAREMIBRAIN is a medical device that received FDA 510(k) clearance on 2023-09-21. The listed applicant is General Equipment For Medical Imaging, S.A.. The 510(k) number is K232569.

When did CAREMIBRAIN receive FDA 510(k) clearance?

CAREMIBRAIN received FDA 510(k) clearance on 2023-09-21, under 510(k) number K232569.

Who is the listed applicant for CAREMIBRAIN?

The FDA 510(k) record lists General Equipment For Medical Imaging, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAREMIBRAIN?

The FDA product code for CAREMIBRAIN is KPS.

Zugehörige klinische Studien

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Verwandte Geräte (Code: KPS)

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