FDA 510(k)

BcSs-PICNI-2000 Sensor

Número K: K182073 · 2019-10-17

RequerenteBraincare Desenvolvimento E Inovacao Tecnologica S.A.

Data da decisão2019-10-17

Código do produtoGWM

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

BcSs-PICNI-2000 Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Braincare Desenvolvimento E Inovacao Tecnologica S.A.. It received FDA 510(k) clearance on 2019-10-17 under 510(k) number K182073. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BcSs-PICNI-2000 Sensor?

BcSs-PICNI-2000 Sensor is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is Braincare Desenvolvimento E Inovacao Tecnologica S.A.. The 510(k) number is K182073.

When did BcSs-PICNI-2000 Sensor receive FDA 510(k) clearance?

BcSs-PICNI-2000 Sensor received FDA 510(k) clearance on 2019-10-17, under 510(k) number K182073.

Who is the listed applicant for BcSs-PICNI-2000 Sensor?

The FDA 510(k) record lists Braincare Desenvolvimento E Inovacao Tecnologica S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BcSs-PICNI-2000 Sensor?

The FDA product code for BcSs-PICNI-2000 Sensor is GWM.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Braincare Desenvolvimento E Inovacao Tecnologica S.A. como candidato(a)

K201989B4C System

Dispositivos Relacionados (Código: GWM)

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa K250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AG K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production Corporation K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.