FDA 510(k)

馬格韋恩 TMS治療 – 用於治療強迫症，馬格韋恩 TMS治療系統

K 號：K193006 · 2020-08-09

決定日期2020-08-09

產品代碼QCI

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

MagVenture TMS Therapy – for treatment of OCD, 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 2020-08-09 under 510(k) number K193006. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system?

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system is a medical device that received FDA 510(k) clearance on 2020-08-09. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K193006.

When did MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system receive FDA 510(k) clearance?

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system received FDA 510(k) clearance on 2020-08-09, under 510(k) number K193006.

Who is the listed applicant for MagVenture TMS Therapy – for treatment of OCD, 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 – for treatment of OCD, MagVenture TMS Therapy system?

The FDA product code for MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system is QCI.

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

查看所有 14 項裝置 →

相關器械（代碼：QCI）

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。

K243459最終經颅磁刺激治療強迫症（M系列）Brain Ultimate, Inc.K230657BTL-99-OCBTL Industries, Inc.K233742雲TMS Edge 用於OCDTeleemg, LLC K231350OCD MT Cap (85-00397-000)Neuronetics K221129雲TMS用於OCDTeleemg, LLC K212289神經星先進治療法用於OCD的輔助治療，神經星先進治療系統，神經星TMS治療系統，神經星先進治療法用於精神健康，神經星Neuronetics, Inc.

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。