FDA 510(k)

CAREMIBRAIN

K号: K232569 · 2023-09-21

申请人General Equipment For Medical Imaging, S.A.

决定日期2023-09-21

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

相关器械（代码：KPS）

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器械摘要

常见问题

相关临床试验

相关器械（代码：KPS）

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