FDA 510(k)

醫療設備名稱：Lingo血糖系統

K 號：K233655 · 2024-05-29

申請人Abbott

決定日期2024-05-29

產品代碼SAF

諮詢委員會CH

決定相當於

器材摘要

Lingo Glucose System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2024-05-29 under 510(k) number K233655. The device is classified under product code SAF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lingo Glucose System?

Lingo Glucose System is a medical device that received FDA 510(k) clearance on 2024-05-29. The listed applicant is Abbott. The 510(k) number is K233655.

When did Lingo Glucose System receive FDA 510(k) clearance?

Lingo Glucose System received FDA 510(k) clearance on 2024-05-29, under 510(k) number K233655.

Who is the listed applicant for Lingo Glucose System?

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

What is the FDA product code for Lingo Glucose System?

The FDA product code for Lingo Glucose System is SAF.

其他以 Abbott 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。

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相關器械（代碼：SAF）

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。

K261359Stelo 葡萄糖生物感測系統Dexcom, Inc.K250106Signos血糖監測系統Signos, Inc.K234070Stelo 葡萄糖生物感測系統Dexcom, Inc.

官方來源

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