FDA 510(k)

NeuroStar Advanced Therapy System (All previously cleared models)

Número K: K231926 · 2024-03-22

Data da decisão2024-03-22

Código do produtoOBP

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

NeuroStar Advanced Therapy System (All previously cleared models) is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics, Inc.. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K231926. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NeuroStar Advanced Therapy System (All previously cleared models)?

NeuroStar Advanced Therapy System (All previously cleared models) is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Neuronetics, Inc.. The 510(k) number is K231926.

When did NeuroStar Advanced Therapy System (All previously cleared models) receive FDA 510(k) clearance?

NeuroStar Advanced Therapy System (All previously cleared models) received FDA 510(k) clearance on 2024-03-22, under 510(k) number K231926.

Who is the listed applicant for NeuroStar Advanced Therapy System (All previously cleared models)?

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

What is the FDA product code for NeuroStar Advanced Therapy System (All previously cleared models)?

The FDA product code for NeuroStar Advanced Therapy System (All previously cleared models) is OBP.

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 Neuronetics, Inc. como candidato(a)

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: OBP)

K260396KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)Fidelity BioPharma Co.K260691BTL-699BTL Industries, Inc.K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S K260560Sistema de Terapia TMS Apollo; Sistema de Terapia TMS Apollo lightMag & More GmbH K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj

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.