Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health

N.º K: K220127 · 2022-07-15

SolicitanteNeuronetics, Inc.
Fecha de decisión2022-07-15
Código de productoOBP
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics, Inc.. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K220127. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health?

NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Neuronetics, Inc.. The 510(k) number is K220127.

When did NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health receive FDA 510(k) clearance?

NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health received FDA 510(k) clearance on 2022-07-15, under 510(k) number K220127.

Who is the listed applicant for NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health?

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 TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health?

The FDA product code for NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health is OBP.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Neuronetics, Inc. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K231926NeuroStar Advanced Therapy System (All previously cleared models)K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental HealthK212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStarK213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental HealthK201158NeuroStar Advanced TherapyK161519NeuroStar TMS Therapy System

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: OBP)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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/SK260560Sistema de Terapia TMS Apollo; Sistema de Terapia TMS Apollo lightMag & More GmbHK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑