CAREMIBRAIN— 510(k) K232569

Substantially Equivalent

General Equipment For Medical Imaging, S.A.

FDA 510(k) clearance K232569 for CAREMIBRAIN, Substantially Equivalent on 2023-09-21. Applicant: General Equipment For Medical Imaging, S.A.. Device class: 2.

Clearance details

Applicant
General Equipment For Medical Imaging, S.A.
Product code
Code KPS
Device class
Class 2
Regulation
21 CFR 892.1200
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Valencia, ES
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