FDA 510(k)

神經軟體TMS

K 號：K160309 · 2016-12-22

決定日期2016-12-22

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

Neurosoft TMS is the device name listed in this FDA 510(k) record. The listed applicant is Teleemg, LLC. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K160309. 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 Neurosoft TMS?

Neurosoft TMS is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Teleemg, LLC. The 510(k) number is K160309.

When did Neurosoft TMS receive FDA 510(k) clearance?

Neurosoft TMS received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160309.

Who is the listed applicant for Neurosoft TMS?

The FDA 510(k) record lists Teleemg, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neurosoft TMS?

The FDA product code for Neurosoft TMS is OBP.

其他以 Teleemg, LLC 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。

K250689雲TMS Edge K233742雲TMS Edge 用於OCD K221129雲TMS用於OCD K173441神經軟體TMS（亦稱為CloudTMS）

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

官方來源

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