FDA 510(k)

Sleepiz One+

K 號：K223163 · 2023-08-18

決定日期2023-08-18

產品代碼DRT

諮詢委員會履歷

決定相當於

器材摘要

Sleepiz One+ is the device name listed in this FDA 510(k) record. The listed applicant is Sleepiz AG. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K223163. 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+?

Sleepiz One+ is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Sleepiz AG. The 510(k) number is K223163.

When did Sleepiz One+ receive FDA 510(k) clearance?

Sleepiz One+ received FDA 510(k) clearance on 2023-08-18, under 510(k) number K223163.

Who is the listed applicant for Sleepiz One+?

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+?

The FDA product code for Sleepiz One+ is DRT.

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。

K253388Sleepiz One+（型號 2.5）K251364Sleepiz One+ (2.5)

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™ (v1)Life Detection Technologies K261286Circadia C300 系統（C300）Circadia Health, Inc.K252676Circadia C300 系統（C300）Circadia Health, Inc.K253388Sleepiz One+（型號 2.5）Sleepiz AG K251364Sleepiz One+ (2.5)Sleepiz AG K234003Circadia C200 系統Circadia Technologies, Ltd.

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。