FDA 510(k)

Dexcom G7 15天連續血糖監測系統

K 號：K243214 · 2025-04-09

決定日期2025-04-09

產品代碼QBJ

諮詢委員會CH

決定相當於

器材摘要

Dexcom G7 15 Day Continuous Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Dexcom, Inc.. It received FDA 510(k) clearance on 2025-04-09 under 510(k) number K243214. The device is classified under product code QBJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dexcom G7 15 Day Continuous Glucose Monitoring System?

Dexcom G7 15 Day Continuous Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2025-04-09. The listed applicant is Dexcom, Inc.. The 510(k) number is K243214.

When did Dexcom G7 15 Day Continuous Glucose Monitoring System receive FDA 510(k) clearance?

Dexcom G7 15 Day Continuous Glucose Monitoring System received FDA 510(k) clearance on 2025-04-09, under 510(k) number K243214.

Who is the listed applicant for Dexcom G7 15 Day Continuous Glucose Monitoring System?

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 G7 15 Day Continuous Glucose Monitoring System?

The FDA product code for Dexcom G7 15 Day Continuous Glucose Monitoring System is QBJ.

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：QBJ）

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。

K261402Dexcom G7 持續血糖監測系統；Dexcom G7 15日持續血糖監測系統Dexcom, Inc.K253737Dexcom G7 持續血糖監測（CGM）系統；Dexcom G7 15日持續血糖監測（CGM）系統Dexcom, Inc.K253710Dexcom G7 持續血糖監測（CGM）系統，Dexcom G7 15日持續血糖監測（CGM）系統Dexcom, Inc.K233537FreeStyle Libre 3 維持血糖監測系統；FreeStyle Libre 2 閃爍血糖監測系統Abbott Diabetes Care, Inc.K240902Dexcom G7 持續血糖監測系統Dexcom, Inc.K234133Dexcom G7 持續血糖監測系統Dexcom, Inc.

官方來源

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