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FDA 510(k)

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

Número K: K220127 · 2022-07-15

RequerenteNeuronetics, Inc.
Data da decisão2022-07-15
Código do produtoOBP
Comité consultivoNE
DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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Outros registros que listam Neuronetics, Inc. como candidato(a)

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Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: OBP)

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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

Fonte oficial

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