睡眠階段機器人
K 號：K233438 · 2024-03-08
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器材摘要
SleepStageML is the device name listed in this FDA 510(k) record. The listed applicant is Beacon Biosignals, Inc.. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K233438. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SleepStageML?
SleepStageML is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Beacon Biosignals, Inc.. The 510(k) number is K233438.
When did SleepStageML receive FDA 510(k) clearance?
SleepStageML received FDA 510(k) clearance on 2024-03-08, under 510(k) number K233438.
Who is the listed applicant for SleepStageML?
FDA 510(k) 記錄將Beacon Biosignals, Inc. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for SleepStageML?
The FDA product code for SleepStageML is OLZ.
相關臨床試驗
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其他以 Beacon Biosignals, 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。
相關器械（代碼：OLZ）
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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