DELTAWAVE 鼻枕系統
K 號：K233415 · 2024-07-02
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器材摘要
DELTAWAVE Nasal Pillows System is the device name listed in this FDA 510(k) record. The listed applicant is Remsleep Holdings. It received FDA 510(k) clearance on 2024-07-02 under 510(k) number K233415. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DELTAWAVE Nasal Pillows System?
DELTAWAVE Nasal Pillows System is a medical device that received FDA 510(k) clearance on 2024-07-02. The listed applicant is Remsleep Holdings. The 510(k) number is K233415.
When did DELTAWAVE Nasal Pillows System receive FDA 510(k) clearance?
DELTAWAVE Nasal Pillows System received FDA 510(k) clearance on 2024-07-02, under 510(k) number K233415.
Who is the listed applicant for DELTAWAVE Nasal Pillows System?
The FDA 510(k) record lists Remsleep Holdings as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DELTAWAVE Nasal Pillows System?
The FDA product code for DELTAWAVE Nasal Pillows System is BZD.
相關臨床試驗
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相關器械（代碼：BZD）
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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