FDA 510(k)

Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation

Número K: K211389 · 2021-09-14

Data da decisão2021-09-14

Código do produtoOBP

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation is the device name listed in this FDA 510(k) record. The listed applicant is Magstim Company, Ltd.. It received FDA 510(k) clearance on 2021-09-14 under 510(k) number K211389. 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 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation?

Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation is a medical device that received FDA 510(k) clearance on 2021-09-14. The listed applicant is Magstim Company, Ltd.. The 510(k) number is K211389.

When did Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation receive FDA 510(k) clearance?

Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation received FDA 510(k) clearance on 2021-09-14, under 510(k) number K211389.

Who is the listed applicant for Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation?

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

What is the FDA product code for Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation?

The FDA product code for Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation is OBP.

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Outros registros que listam Magstim Company, Ltd. como candidato(a)

K223154Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+K222171Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+K203684Neurosign V4 Intraoperative Nerve Monitor K183376HORIZON TMS Therapy System with Navigation K182853HORIZON TMS Therapy System K181559Neurosign V4 Intraoperative Nerve Monitor

Ver todos os 10 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

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