Sleepiz One+ (Model 2.5)
K 號：K253388 · 2026-01-28
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器材摘要
Sleepiz One+ (Model 2.5) is the device name listed in this FDA 510(k) record. The listed applicant is Sleepiz AG. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K253388. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Sleepiz One+ (Model 2.5)?
Sleepiz One+ (Model 2.5) is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Sleepiz AG. The 510(k) number is K253388.
When did Sleepiz One+ (Model 2.5) receive FDA 510(k) clearance?
Sleepiz One+ (Model 2.5) received FDA 510(k) clearance on 2026-01-28, under 510(k) number K253388.
Who is the listed applicant for Sleepiz One+ (Model 2.5)?
The FDA 510(k) record lists Sleepiz AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sleepiz One+ (Model 2.5)?
The FDA product code for Sleepiz One+ (Model 2.5) is DRT.
相關臨床試驗
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其他以 Sleepiz AG 為申請人之記錄
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：DRT）
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。
K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.K232354Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server SoftwareMurata Vios, Inc.
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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