睡眠檢查器
K 號：K223676 · 2023-06-01
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器材摘要
SomniCheck is the device name listed in this FDA 510(k) record. The listed applicant is Brainmatterz, LLC. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K223676. 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 SomniCheck?
SomniCheck is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Brainmatterz, LLC. The 510(k) number is K223676.
When did SomniCheck receive FDA 510(k) clearance?
SomniCheck received FDA 510(k) clearance on 2023-06-01, under 510(k) number K223676.
Who is the listed applicant for SomniCheck?
The FDA 510(k) record lists Brainmatterz, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SomniCheck?
The FDA product code for SomniCheck is GWL.
相關臨床試驗
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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。
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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