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FDA 510(k)

Accu-Chek Solo micropump system with interoperable technology

K 號：K213134 · 2023-08-10

申請人Roche Diabetes Care GmbH
決定日期2023-08-10
產品代碼QFG
諮詢委員會CH
決定相當於

器材摘要

Accu-Chek Solo micropump system with interoperable technology is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diabetes Care GmbH. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K213134. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Accu-Chek Solo micropump system with interoperable technology?

Accu-Chek Solo micropump system with interoperable technology is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Roche Diabetes Care GmbH. The 510(k) number is K213134.

When did Accu-Chek Solo micropump system with interoperable technology receive FDA 510(k) clearance?

Accu-Chek Solo micropump system with interoperable technology received FDA 510(k) clearance on 2023-08-10, under 510(k) number K213134.

Who is the listed applicant for Accu-Chek Solo micropump system with interoperable technology?

The FDA 510(k) record lists Roche Diabetes Care GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accu-Chek Solo micropump system with interoperable technology?

The FDA product code for Accu-Chek Solo micropump system with interoperable technology is QFG.

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

其他以 Roche Diabetes Care GmbH 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。

K213131Accu-Chek Guide Solo diabetes manager blood glucose monitoring system

相關器械（代碼：QFG）

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。

K260001薄荷ACE泵Beta Bionics, Inc.K261672twiist自動胰島素輸送（AID）系統Deka Research and DevelopmentK253976iLet ACE 泵Beta Bionics, Inc.K253743迷你美德Flex泵Medtronic Minimed, Inc.K253470MiniMed 780G 胰島素針筒 (MMT-1884)；MiniMed 780G 胰島素針筒組合包 (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi 胰島素針筒配互操作性技術Tandem Diabetes Care, Inc.

官方來源

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