FDA 510(k)

NeuroOne Cortical Electrode

Número K: K192764 · 2019-11-26

Data da decisão2019-11-26

Código do produtoGYC

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

NeuroOne Cortical Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Neuroone, Inc.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192764. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NeuroOne Cortical Electrode?

NeuroOne Cortical Electrode is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Neuroone, Inc.. The 510(k) number is K192764.

When did NeuroOne Cortical Electrode receive FDA 510(k) clearance?

NeuroOne Cortical Electrode received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192764.

Who is the listed applicant for NeuroOne Cortical Electrode?

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

What is the FDA product code for NeuroOne Cortical Electrode?

The FDA product code for NeuroOne Cortical Electrode is GYC.

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: GYC)

K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)Neuralynx, Inc.K242618Layer 7-TPrecision Neuroscience, Corp.K221123WISE Cortical Strip (WCS)Wise S.R.L.K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping GridSpes Medica Srl K201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)Dixi Medical K191346Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)Blackrock Microsystems

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.