FDA 510(k)

春TMS

K 號：K182976 · 2019-02-25

決定日期2019-02-25

產品代碼OKP

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

SpringTMS is the device name listed in this FDA 510(k) record. The listed applicant is Eneura®, Inc.. It received FDA 510(k) clearance on 2019-02-25 under 510(k) number K182976. The device is classified under product code OKP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SpringTMS?

SpringTMS is a medical device that received FDA 510(k) clearance on 2019-02-25. The listed applicant is Eneura®, Inc.. The 510(k) number is K182976.

When did SpringTMS receive FDA 510(k) clearance?

SpringTMS received FDA 510(k) clearance on 2019-02-25, under 510(k) number K182976.

Who is the listed applicant for SpringTMS?

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

What is the FDA product code for SpringTMS?

The FDA product code for SpringTMS is OKP.

其他以 Eneura®, 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。

K230358SAVI雙效（TM）偏頭痛治療 K162797春TMS K161663sTMS迷你

相關器械（代碼：OKP）

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。

K230358SAVI雙效（TM）偏頭痛治療Eneura, Inc.K162797春TMSEneura, Inc.K161663sTMS迷你Eneura, Inc.

官方來源

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