FDA 510(k)

最終經颅磁刺激器

K 號：K243460 · 2025-04-17

決定日期2025-04-17

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

Ultimate rTMS is the device name listed in this FDA 510(k) record. The listed applicant is Brain Ultimate, Inc.. It received FDA 510(k) clearance on 2025-04-17 under 510(k) number K243460. 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 Ultimate rTMS?

Ultimate rTMS is a medical device that received FDA 510(k) clearance on 2025-04-17. The listed applicant is Brain Ultimate, Inc.. The 510(k) number is K243460.

When did Ultimate rTMS receive FDA 510(k) clearance?

Ultimate rTMS received FDA 510(k) clearance on 2025-04-17, under 510(k) number K243460.

Who is the listed applicant for Ultimate rTMS?

FDA 510(k) 記錄將 Brain Ultimate, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Ultimate rTMS?

The FDA product code for Ultimate rTMS is OBP.

其他以 Brain Ultimate, Inc. 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。

K261228QuickVision Ultimate rTMS K243459最終經颅磁刺激治療強迫症（M系列）K230735最終rTMS；盈池rTMS

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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