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FDA 510(k)

HORIZON TMS Therapy System with Navigation

K-Number: K183376 · 2019-04-03

Decision Date2019-04-03
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HORIZON TMS Therapy System 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 2019-04-03 under 510(k) 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. The listed applicant is Magstim Company, Ltd.. The 510(k) number is K183376.

When did HORIZON TMS Therapy System with Navigation receive FDA 510(k) clearance?

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

Who is the listed applicant for HORIZON TMS Therapy System 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 HORIZON TMS Therapy System with Navigation?

The FDA product code for HORIZON TMS Therapy System 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.

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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.

Official Source

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