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FDA 510(k)

HORIZON TMS Therapy System with Navigation

K-Number: K183376 · 2019-04-03

ApplicantMagstim Company, Ltd.
Decision Date2019-04-03
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HORIZON TMS Therapy System with Navigation is a medical device manufactured by Magstim Company, Ltd.. It received FDA 510(k) clearance on 2019-04-03 under approval number K183376. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HORIZON TMS Therapy System with Navigation?

HORIZON TMS Therapy System with Navigation is a medical device that received FDA 510(k) clearance on 2019-04-03. It is manufactured by Magstim Company, Ltd.. The 510(k) number is K183376.

When was HORIZON TMS Therapy System with Navigation approved by the FDA?

HORIZON TMS Therapy System with Navigation received FDA 510(k) clearance on 2019-04-03, under approval number K183376.

What company makes HORIZON TMS Therapy System with Navigation?

HORIZON TMS Therapy System with Navigation is manufactured by Magstim Company, Ltd..

What is the FDA product code for HORIZON TMS Therapy System with Navigation?

The FDA product code for HORIZON TMS Therapy System with Navigation is OBP.

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Related PubMed Literature

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Other Devices by Magstim Company, Ltd.

K171051HORIZON Therapy System K162935Rapid2 Therapy System K181559Neurosign V4 Intraoperative Nerve Monitor K180907HORIZON TMS Therapy System K182853HORIZON TMS Therapy System K211389Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation

View all 10 devices →

Related Devices (Code: OBP)

K160309Neurosoft TMSTeleemg, LLC K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC K171902Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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