FDA 510(k)

Rafugen DBM

N.º K: K180121 · 2018-04-11

Fecha de decisión2018-04-11

Código de productoMQV

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Rafugen DBM is the device name listed in this FDA 510(k) record. The listed applicant is Cellumed Co., Ltd.. It received FDA 510(k) clearance on 2018-04-11 under 510(k) number K180121. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Rafugen DBM?

Rafugen DBM is a medical device that received FDA 510(k) clearance on 2018-04-11. The listed applicant is Cellumed Co., Ltd.. The 510(k) number is K180121.

When did Rafugen DBM receive FDA 510(k) clearance?

Rafugen DBM received FDA 510(k) clearance on 2018-04-11, under 510(k) number K180121.

Who is the listed applicant for Rafugen DBM?

The FDA 510(k) record lists Cellumed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rafugen DBM?

The FDA product code for Rafugen DBM is MQV.

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: MQV)

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.