FDA 510(k)

Cervello STIM

Número K: K151354 · 2016-01-27

Data da decisão2016-01-27

Código do produtoGYC

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cervello STIM is the device name listed in this FDA 510(k) record. The listed applicant is Blackrock Neuromed. It received FDA 510(k) clearance on 2016-01-27 under 510(k) number K151354. 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 Cervello STIM?

Cervello STIM is a medical device that received FDA 510(k) clearance on 2016-01-27. The listed applicant is Blackrock Neuromed. The 510(k) number is K151354.

When did Cervello STIM receive FDA 510(k) clearance?

Cervello STIM received FDA 510(k) clearance on 2016-01-27, under 510(k) number K151354.

Who is the listed applicant for Cervello STIM?

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

What is the FDA product code for Cervello STIM?

The FDA product code for Cervello STIM 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.