FDA 510(k)

BE Plus PRO, Neurotravel LIGHT

K 號：K242305 · 2024-09-04

決定日期2024-09-04

產品代碼GWL

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

BE Plus PRO, Neurotravel LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Eb Neuro S.P.A.. It received FDA 510(k) clearance on 2024-09-04 under 510(k) number K242305. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BE Plus PRO, Neurotravel LIGHT?

BE Plus PRO, Neurotravel LIGHT is a medical device that received FDA 510(k) clearance on 2024-09-04. The listed applicant is Eb Neuro S.P.A.. The 510(k) number is K242305.

When did BE Plus PRO, Neurotravel LIGHT receive FDA 510(k) clearance?

BE Plus PRO, Neurotravel LIGHT received FDA 510(k) clearance on 2024-09-04, under 510(k) number K242305.

Who is the listed applicant for BE Plus PRO, Neurotravel LIGHT?

The FDA 510(k) record lists Eb Neuro S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BE Plus PRO, Neurotravel LIGHT?

The FDA product code for BE Plus PRO, Neurotravel LIGHT is GWL.

其他以 Eb Neuro S.P.A. 為申請人之記錄

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相關器械（代碼：GWL）

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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