馬格韋恩 TMS治療系統
K 號：K251125 · 2025-08-11
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器材摘要
MagVenture TMS Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Tonica Elektronik A/S. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K251125. 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 MagVenture TMS Therapy System?
MagVenture TMS Therapy System is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K251125.
When did MagVenture TMS Therapy System receive FDA 510(k) clearance?
MagVenture TMS Therapy System received FDA 510(k) clearance on 2025-08-11, under 510(k) number K251125.
Who is the listed applicant for MagVenture TMS Therapy System?
The FDA 510(k) record lists Tonica Elektronik A/S as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MagVenture TMS Therapy System?
The FDA product code for MagVenture TMS Therapy System is OBP.
相關臨床試驗
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。
其他以 Tonica Elektronik A/S 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。
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/SK260560Apollo TMS治療系統; Apollo light TMS治療系統Mag & More GmbHK253098Nexstim導向性腦刺激(NBS) 6系統(NBS6)Nexstim Oyj
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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