FDA 510(k)

Magstim Horizon 3.0 TMS治療系統，Horizon 3.0 系統，Horizon 3.0，配導航的Horizon 3.0

K 號：K211389 · 2021-09-14

決定日期2021-09-14

產品代碼OBP

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

其他以 Magstim Company, Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K223154Magstim Horizon 3.0 TMS治療系統，Horizon 3.0系統，Horizon 3.0，H3.0，配備StimGuide+的Horizon 3.0 K222171Magstim Horizon 3.0 TMS治療系統，Horizon 3.0系統，Horizon 3.0，H3.0，配備StimGuide+的Horizon 3.0 K203684神經信號V4手術中神經監視器 K183376HORIZON TMS治療系統配導航功能 K182853HORIZON TMS治療系統 K181559神經信號V4手術中神經監視器

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相關器械（代碼：OBP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260396KCS rTMS治療系統（經颅磁刺激器）（MetaStim 100，MetaStim 100A）Fidelity BioPharma Co.K260691BTL-699BTL Industries, Inc.K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260189馬格韋恩加速經颅磁刺激治療系統（aTMS）Tonica Elektronik A/S K260560Apollo TMS治療系統; Apollo light TMS治療系統Mag & More GmbH K253098Nexstim導向性腦刺激(NBS) 6系統(NBS6)Nexstim Oyj

官方來源

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