NEBA® 精簡型 EEG2R 行動式頭戴式耳機
K 號：K223628 · 2023-03-02
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器材摘要
NEBA® Compact EEG2R Mobile Headset is the device name listed in this FDA 510(k) record. The listed applicant is Neba Health, LLC. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K223628. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the NEBA® Compact EEG2R Mobile Headset?
NEBA® Compact EEG2R Mobile Headset is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Neba Health, LLC. The 510(k) number is K223628.
When did NEBA® Compact EEG2R Mobile Headset receive FDA 510(k) clearance?
NEBA® Compact EEG2R Mobile Headset received FDA 510(k) clearance on 2023-03-02, under 510(k) number K223628.
Who is the listed applicant for NEBA® Compact EEG2R Mobile Headset?
The FDA 510(k) record lists Neba Health, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NEBA® Compact EEG2R Mobile Headset?
The FDA product code for NEBA® Compact EEG2R Mobile Headset is OMC.
相關臨床試驗
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相關器械（代碼：OMC）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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