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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

K-Number: K211389 · 2021-09-14

ApplicantMagstim Company, Ltd.
Decision Date2021-09-14
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Magstim Company, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 MonitorK183376HORIZON TMS Therapy System with NavigationK182853HORIZON TMS Therapy SystemK181559Neurosign V4 Intraoperative Nerve Monitor

View all 10 devices →

Related Devices (Code: OBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.

Official Source

View on FDA Database →

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