FDA 510(k)

Apollo TMS治療系統; Apollo light TMS治療系統

K 號：K260560 · 2026-05-22

決定日期2026-05-22

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

Apollo TMS Therapy System;Apollo light TMS Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Mag & More GmbH. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K260560. 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 Apollo TMS Therapy System;Apollo light TMS Therapy System?

Apollo TMS Therapy System;Apollo light TMS Therapy System is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Mag & More GmbH. The 510(k) number is K260560.

When did Apollo TMS Therapy System;Apollo light TMS Therapy System receive FDA 510(k) clearance?

Apollo TMS Therapy System;Apollo light TMS Therapy System received FDA 510(k) clearance on 2026-05-22, under 510(k) number K260560.

Who is the listed applicant for Apollo TMS Therapy System;Apollo light TMS Therapy System?

The FDA 510(k) record lists Mag & More GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Apollo TMS Therapy System;Apollo light TMS Therapy System?

The FDA product code for Apollo TMS Therapy System;Apollo light TMS Therapy System is OBP.

其他以 Mag & More GmbH 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。

K243700Apollo TMS治療系統 K243539Apollo TMS治療系統 K232639Apollo TMS治療系統 K180313Apollo TMS治療系統

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 K253098Nexstim導向性腦刺激(NBS) 6系統(NBS6)Nexstim Oyj K252358Nexstim導向性腦刺激(NBS) 6系統(NBS6)Nexstim Oyj

官方來源

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