夢淨清
K 號：K240646 · 2024-09-04
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決定日期2024-09-04
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
DreamClear is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed Technologies Inc., Doing Business AS Remware. It received FDA 510(k) clearance on 2024-09-04 under 510(k) number K240646. 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 DreamClear?
DreamClear is a medical device that received FDA 510(k) clearance on 2024-09-04. The listed applicant is Somnomed Technologies Inc., Doing Business AS Remware. The 510(k) number is K240646.
When did DreamClear receive FDA 510(k) clearance?
DreamClear received FDA 510(k) clearance on 2024-09-04, under 510(k) number K240646.
Who is the listed applicant for DreamClear?
The FDA 510(k) record lists Somnomed Technologies Inc., Doing Business AS Remware as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DreamClear?
The FDA product code for DreamClear is GWL.
相關臨床試驗
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：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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