FDA 510(k)

SISTEMA DE MONITORAMENTO DE ICP AURA

Número K: K172209 · 2018-05-18

RequerenteBranchpoint Technologies, Inc.

Data da decisão2018-05-18

Código do produtoGWM

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

AURA ICP MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Branchpoint Technologies, Inc.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K172209. 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 AURA ICP MONITORING SYSTEM?

AURA ICP MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Branchpoint Technologies, Inc.. The 510(k) number is K172209.

When did AURA ICP MONITORING SYSTEM receive FDA 510(k) clearance?

AURA ICP MONITORING SYSTEM received FDA 510(k) clearance on 2018-05-18, under 510(k) number K172209.

Who is the listed applicant for AURA ICP MONITORING SYSTEM?

The FDA 510(k) record lists Branchpoint Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AURA ICP MONITORING SYSTEM?

The FDA product code for AURA ICP MONITORING SYSTEM 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

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.