FDA 510(k)

麥維塔TMS治療系統搭配Theta爆發刺激

K 號：K173620 · 2018-08-14

決定日期2018-08-14

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

Mag Vita TMS Therapy System w/Theta Burst Stimulation 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 2018-08-14 under 510(k) number K173620. 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 Mag Vita TMS Therapy System w/Theta Burst Stimulation?

Mag Vita TMS Therapy System w/Theta Burst Stimulation is a medical device that received FDA 510(k) clearance on 2018-08-14. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K173620.

When did Mag Vita TMS Therapy System w/Theta Burst Stimulation receive FDA 510(k) clearance?

Mag Vita TMS Therapy System w/Theta Burst Stimulation received FDA 510(k) clearance on 2018-08-14, under 510(k) number K173620.

Who is the listed applicant for Mag Vita TMS Therapy System w/Theta Burst Stimulation?

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 Mag Vita TMS Therapy System w/Theta Burst Stimulation?

The FDA product code for Mag Vita TMS Therapy System w/Theta Burst Stimulation is OBP.

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。

K260189馬格韋恩加速經颅磁刺激治療系統（aTMS）K251125馬格韋恩 TMS治療系統 K251119馬格韋恩 TMS治療系統 K252032T65 (9016E061-)K230014馬格韻痛療法：MagPro R30、MagPro R30 配備 MagOption、MagPro X100、MagPro X100 配備 MagOption K221544馬格韋恩特 TMS 阿特拉斯神經導航系統

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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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