FDA 510(k)

MEGA-TMS

K 號：K192823 · 2021-08-13

決定日期2021-08-13

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

MEGA-TMS is the device name listed in this FDA 510(k) record. The listed applicant is Soterix Medical, Inc.. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K192823. 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 MEGA-TMS?

MEGA-TMS is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Soterix Medical, Inc.. The 510(k) number is K192823.

When did MEGA-TMS receive FDA 510(k) clearance?

MEGA-TMS received FDA 510(k) clearance on 2021-08-13, under 510(k) number K192823.

Who is the listed applicant for MEGA-TMS?

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

What is the FDA product code for MEGA-TMS?

The FDA product code for MEGA-TMS is GWF.

其他以 Soterix Medical, Inc. 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。

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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。

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官方來源

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