FDA 510(k)

t:slim X2 胰島素針筒搭配互操作性技術（含 t:connect 行動應用程式）

K 號：K203234 · 2022-02-15

決定日期2022-02-15

產品代碼QFG

諮詢委員會CH

決定相當於

器材摘要

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) is the device name listed in this FDA 510(k) record. The listed applicant is Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2022-02-15 under 510(k) number K203234. 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 t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)?

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) is a medical device that received FDA 510(k) clearance on 2022-02-15. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K203234.

When did t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) receive FDA 510(k) clearance?

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) received FDA 510(k) clearance on 2022-02-15, under 510(k) number K203234.

Who is the listed applicant for t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)?

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

What is the FDA product code for t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)?

The FDA product code for t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) is QFG.

其他以 Tandem Diabetes Care, 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。

K260429控制-IQ+技術 K253074Tandem Mobi 胰島素針筒配互操作性技術 K250792t:slim X2 胰島素泵，配備互操作性技術 K250798控制-IQ+技術 K243823控制-IQ+技術 K241078Tandem Mobi 胰島素針筒，配備互操作性技術

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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 Development K253976iLet 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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