FDA 510(k)

CAREMIBRAIN

K-Number: K232569 · 2023-09-21

ApplicantGeneral Equipment For Medical Imaging, S.A.

Decision Date2023-09-21

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: KPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.