睡眠分析器
K 號：K153412 · 2016-03-14
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器材摘要
Sleep Profiler is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Brain Monitoring, Inc.. It received FDA 510(k) clearance on 2016-03-14 under 510(k) number K153412. 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 Sleep Profiler?
Sleep Profiler is a medical device that received FDA 510(k) clearance on 2016-03-14. The listed applicant is Advanced Brain Monitoring, Inc.. The 510(k) number is K153412.
When did Sleep Profiler receive FDA 510(k) clearance?
Sleep Profiler received FDA 510(k) clearance on 2016-03-14, under 510(k) number K153412.
Who is the listed applicant for Sleep Profiler?
The FDA 510(k) record lists Advanced Brain Monitoring, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sleep Profiler?
The FDA product code for Sleep Profiler is OLZ.
相關臨床試驗
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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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