FDA 510(k)

FreeStyle Libre 3 維持血糖監測系統；FreeStyle Libre 2 閃爍血糖監測系統

K 號：K223435 · 2023-04-13

決定日期2023-04-13

產品代碼QBJ

諮詢委員會CH

決定相當於

器材摘要

FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K223435. 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 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System?

FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K223435.

When did FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System receive FDA 510(k) clearance?

FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System received FDA 510(k) clearance on 2023-04-13, under 510(k) number K223435.

Who is the listed applicant for FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System?

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

What is the FDA product code for FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System?

The FDA product code for FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System is QBJ.

其他以 Abbott 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。

K233537FreeStyle Libre 3 維持血糖監測系統；FreeStyle Libre 2 閃爍血糖監測系統 K222447FreeStyle Libre 2 閃電血糖監測系統；Freestyle Libre 3 持續血糖監測系統 K223537FreeStyle Libre 2 系統，FreeStyle Libre 3 系統 K213996FreeStyle Libre 3 維持血糖監測系統 K212132FreeStyle Libre 3 維持血糖監測系統 K210943FreeStyle Libre 2 閃電血糖監測系統（含 FreeStyle Libre 2 App）

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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.K243214Dexcom G7 15天連續血糖監測系統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.

官方來源

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