FDA 510(k)

CAREMIBRAIN

N.º K: K232569 · 2023-09-21

SolicitanteGeneral Equipment For Medical Imaging, S.A.

Fecha de decisión2023-09-21

Código de productoKPS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: KPS)

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.