CAREMIBRAIN
K-Number: K232569 · 2023-09-21
Decision Date2023-09-21
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CAREMIBRAIN is a medical device manufactured by General Equipment For Medical Imaging, S.A.. It received FDA 510(k) clearance on 2023-09-21 under approval 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. It is manufactured by General Equipment For Medical Imaging, S.A.. The 510(k) number is K232569.
When was CAREMIBRAIN approved by the FDA?
CAREMIBRAIN received FDA 510(k) clearance on 2023-09-21, under approval number K232569.
What company makes CAREMIBRAIN?
CAREMIBRAIN is manufactured by General Equipment For Medical Imaging, S.A..
What is the FDA product code for CAREMIBRAIN?
The FDA product code for CAREMIBRAIN is KPS.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.