FDA 510(k)

雲TMS Edge 用於OCD

K 號：K233742 · 2023-12-22

決定日期2023-12-22

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

CloudTMS Edge for OCD is the device name listed in this FDA 510(k) record. The listed applicant is Teleemg, LLC. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K233742. 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 CloudTMS Edge for OCD?

CloudTMS Edge for OCD is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Teleemg, LLC. The 510(k) number is K233742.

When did CloudTMS Edge for OCD receive FDA 510(k) clearance?

CloudTMS Edge for OCD received FDA 510(k) clearance on 2023-12-22, under 510(k) number K233742.

Who is the listed applicant for CloudTMS Edge for OCD?

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 CloudTMS Edge for OCD?

The FDA product code for CloudTMS Edge for OCD is QCI.

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 K221129雲TMS用於OCD K173441神經軟體TMS（亦稱為CloudTMS）K160309神經軟體TMS

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。

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官方來源

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