The Circadia C300 System (C300)
K 號：K261286 · 2026-05-20
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器材摘要
The Circadia C300 System (C300) is the device name listed in this FDA 510(k) record. The listed applicant is Circadia Health, Inc.. It received FDA 510(k) clearance on 2026-05-20 under 510(k) number K261286. 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 The Circadia C300 System (C300)?
The Circadia C300 System (C300) is a medical device that received FDA 510(k) clearance on 2026-05-20. The listed applicant is Circadia Health, Inc.. The 510(k) number is K261286.
When did The Circadia C300 System (C300) receive FDA 510(k) clearance?
The Circadia C300 System (C300) received FDA 510(k) clearance on 2026-05-20, under 510(k) number K261286.
Who is the listed applicant for The Circadia C300 System (C300)?
The FDA 510(k) record lists Circadia Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for The Circadia C300 System (C300)?
The FDA product code for The Circadia C300 System (C300) is DRT.
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其他以 Circadia Health, Inc. 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 TechnologiesK252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz 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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