FDA 510(k)

Dexcom 智能基礎

K 號：K252818 · 2025-11-18

決定日期2025-11-18

產品代碼QRX

諮詢委員會CH

決定相當於

器材摘要

Dexcom Smart Basal is the device name listed in this FDA 510(k) record. The listed applicant is Dexcom, Inc.. It received FDA 510(k) clearance on 2025-11-18 under 510(k) number K252818. The device is classified under product code QRX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dexcom Smart Basal?

Dexcom Smart Basal is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Dexcom, Inc.. The 510(k) number is K252818.

When did Dexcom Smart Basal receive FDA 510(k) clearance?

Dexcom Smart Basal received FDA 510(k) clearance on 2025-11-18, under 510(k) number K252818.

Who is the listed applicant for Dexcom Smart Basal?

FDA 510(k) 記錄將 Dexcom, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Dexcom Smart Basal?

The FDA product code for Dexcom Smart Basal is QRX.

其他以 Dexcom, 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。

K262472Stelo 葡萄糖生物感測系統 K260935Stelo 葡萄糖生物感測系統 K261402Dexcom G7 持續血糖監測系統；Dexcom G7 15日持續血糖監測系統 K261359Stelo 葡萄糖生物感測系統 K253737Dexcom G7 持續血糖監測（CGM）系統；Dexcom G7 15日持續血糖監測（CGM）系統 K253710Dexcom G7 持續血糖監測（CGM）系統，Dexcom G7 15日持續血糖監測（CGM）系統

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相關器械（代碼：QRX）

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。

K260062MODI系統DreaMed Diabetes, Ltd.K231824智慧輸注計算器Insulet Corporation K222888藍星CGM胰島素劑量計算器Welldoc, Inc.K222239智慧輸注計算器Insulet Corporation K203772Omnipod 5 智能輸注計算器Insulet Corporation

官方來源

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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。