FDA 510(k)

t:slim 胰島素輸送系統，t:flex 胰島素輸送系統，Tandem 裝置更新器

K 號：K160482 · 2016-07-13

決定日期2016-07-13

產品代碼LZG

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater 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 2016-07-13 under 510(k) number K160482. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K160482.

When did t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater receive FDA 510(k) clearance?

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater received FDA 510(k) clearance on 2016-07-13, under 510(k) number K160482.

Who is the listed applicant for t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

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 Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

The FDA product code for t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater is LZG.

其他以 Tandem Diabetes Care, Inc. 為申請人之記錄

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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：LZG）

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。

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官方來源

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