FDA 510(k)

NExT Station；NExT Station 高級版

K 號：K242832 · 2024-12-12

決定日期2024-12-12

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

NExT Station; NExT Station Advanced 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 2024-12-12 under 510(k) number K242832. 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 NExT Station; NExT Station Advanced?

NExT Station; NExT Station Advanced is a medical device that received FDA 510(k) clearance on 2024-12-12. The listed applicant is Eb Neuro S.P.A.. The 510(k) number is K242832.

When did NExT Station; NExT Station Advanced receive FDA 510(k) clearance?

NExT Station; NExT Station Advanced received FDA 510(k) clearance on 2024-12-12, under 510(k) number K242832.

Who is the listed applicant for NExT Station; NExT Station Advanced?

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 NExT Station; NExT Station Advanced?

The FDA product code for NExT Station; NExT Station Advanced is GWL.

其他以 Eb Neuro S.P.A. 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。

K242305BE Plus PRO, Neurotravel LIGHT

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。

K243746德菲放大器Quantalx Neroscience K240646夢淨清Somnomed Technologies Inc., Doing Business AS Remware K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.K232210X-trodes 系統 MX-Trodes K230148VlabDormotech Medical, Ltd.K223676睡眠檢查器Brainmatterz, LLC

官方來源

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