FDA 510(k)

MagPro R20

K 號：K160280 · 2016-05-16

決定日期2016-05-16

產品代碼GWF

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

MagPro R20 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 2016-05-16 under 510(k) number K160280. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MagPro R20?

MagPro R20 is a medical device that received FDA 510(k) clearance on 2016-05-16. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K160280.

When did MagPro R20 receive FDA 510(k) clearance?

MagPro R20 received FDA 510(k) clearance on 2016-05-16, under 510(k) number K160280.

Who is the listed applicant for MagPro R20?

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 MagPro R20?

The FDA product code for MagPro R20 is GWF.

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：GWF）

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。

K263010ISIS頭箱，ISIS神經刺激器，ISIS Xpert Plus，ISIS Xpert，ISIS Xpressinomed Medizintechnik GmbH K253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3：神經資訊系統Alphatec Spine, Inc.K243982尼可萊特EDXNatus Neurology Incorporated K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated K242345德菲刺激器Quantalx Neuroscience

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。