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FDA 510(k)

CamAPS FX

K 號：K232603 · 2024-05-23

申請人Camdiab , Ltd.
決定日期2024-05-23
產品代碼QJI
諮詢委員會CH
決定相當於

器材摘要

CamAPS FX is the device name listed in this FDA 510(k) record. The listed applicant is Camdiab , Ltd.. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K232603. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CamAPS FX?

CamAPS FX is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Camdiab , Ltd.. The 510(k) number is K232603.

When did CamAPS FX receive FDA 510(k) clearance?

CamAPS FX received FDA 510(k) clearance on 2024-05-23, under 510(k) number K232603.

Who is the listed applicant for CamAPS FX?

The FDA 510(k) record lists Camdiab , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CamAPS FX?

The FDA product code for CamAPS FX is QJI.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：QJI）

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。

K261896iOS CamAPS FXCamDiabK262763iLet 計劃劑量決策軟體Beta Bionics, Inc.K261962智能守護技術；預測性低血糖技術Medtronic MiniMedK261461Omnipod 6 適配演算法Insulet CorporationK260429控制-IQ+技術Tandem Diabetes Care, Inc.K253701智能守護技術；預測性低血糖技術Medtronic Minimed

官方來源

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