FDA 510(k)

FreeStyle Libre 2 閃電血糖監測系統（含 FreeStyle Libre 2 App）

K 號：K210943 · 2021-11-22

決定日期2021-11-22

產品代碼QLG

諮詢委員會CH

決定相當於

器材摘要

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) 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 2021-11-22 under 510(k) number K210943. The device is classified under product code QLG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)?

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is a medical device that received FDA 510(k) clearance on 2021-11-22. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K210943.

When did FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) receive FDA 510(k) clearance?

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) received FDA 510(k) clearance on 2021-11-22, under 510(k) number K210943.

Who is the listed applicant for FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)?

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 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)?

The FDA product code for FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is QLG.

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 K223435FreeStyle 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

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相關器械（代碼：QLG）

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。

K222280Bigfoot Unity® 糖尿病管理系統Bigfoot Biomedical, Inc.K223537FreeStyle Libre 2 系統，FreeStyle Libre 3 系統Abbott Diabetes Care, Inc.K213996FreeStyle Libre 3 維持血糖監測系統Abbott Diabetes Care, Inc.K212132FreeStyle Libre 3 維持血糖監測系統Abbott Diabetes Care, Inc.K211102FreeStyle Libre 2 閃電式血糖監測系統Abbott Diabetes Care, Inc.K201761FreeStyle Libre 2 閃電血糖監測系統（含 FreeStyle Libre 2 App）Abbott Diabetes Care, Inc.

官方來源

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