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FDA 510(k)

Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro

Número K: K232235 · 2023-10-25

RequerenteThe Magstim Company , Ltd.
Data da decisão2023-10-25
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; Horizon® 3.0 with StimGuide Pro is the device name listed in this FDA 510(k) record. The listed applicant is The Magstim Company , Ltd.. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K232235. 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; Horizon® 3.0 with StimGuide Pro?

Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is The Magstim Company , Ltd.. The 510(k) number is K232235.

When did Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro receive FDA 510(k) clearance?

Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro received FDA 510(k) clearance on 2023-10-25, under 510(k) number K232235.

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; Horizon® 3.0 with StimGuide Pro?

The FDA 510(k) record lists The 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; Horizon® 3.0 with StimGuide Pro?

The FDA product code for Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro is OBP.

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Dispositivos Relacionados (Código: OBP)

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.

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

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