日落加熱CPAP管
K 號：K201418 · 2021-01-29
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器材摘要
Sunset Heated CPAP Tube is the device name listed in this FDA 510(k) record. The listed applicant is Sunset Healthcare Solutions, Inc.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K201418. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Sunset Heated CPAP Tube?
Sunset Heated CPAP Tube is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Sunset Healthcare Solutions, Inc.. The 510(k) number is K201418.
When did Sunset Heated CPAP Tube receive FDA 510(k) clearance?
Sunset Heated CPAP Tube received FDA 510(k) clearance on 2021-01-29, under 510(k) number K201418.
Who is the listed applicant for Sunset Heated CPAP Tube?
The FDA 510(k) record lists Sunset Healthcare Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sunset Heated CPAP Tube?
The FDA product code for Sunset Heated CPAP Tube is BZE.
相關臨床試驗
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相關器械（代碼：BZE）
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。
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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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