免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

自由里奧持續血糖監測系統

K 號:K233861 · 2024-06-07

決定日期2024-06-07
產品代碼SBH
諮詢委員會CH
決定相當於

器材摘要

Libre Rio Continuous Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care. It received FDA 510(k) clearance on 2024-06-07 under 510(k) number K233861. The device is classified under product code SBH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Libre Rio Continuous Glucose Monitoring System?

Libre Rio Continuous Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is Abbott Diabetes Care. The 510(k) number is K233861.

When did Libre Rio Continuous Glucose Monitoring System receive FDA 510(k) clearance?

Libre Rio Continuous Glucose Monitoring System received FDA 510(k) clearance on 2024-06-07, under 510(k) number K233861.

Who is the listed applicant for Libre Rio Continuous Glucose Monitoring System?

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

What is the FDA product code for Libre Rio Continuous Glucose Monitoring System?

The FDA product code for Libre Rio Continuous Glucose Monitoring System is SBH.

相關臨床試驗

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。

相關器械(代碼:SBH)

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。

官方來源

在 FDA 資料庫中查看 →

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。

↑