iSage Rx（iSage Rx 基底胰島素調節）
K 號：K161865 · 2017-03-07
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器材摘要
iSage Rx (iSage Rx Basal Insulin Titration) is the device name listed in this FDA 510(k) record. The listed applicant is Isag Rx, Inc.. It received FDA 510(k) clearance on 2017-03-07 under 510(k) number K161865. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the iSage Rx (iSage Rx Basal Insulin Titration)?
iSage Rx (iSage Rx Basal Insulin Titration) is a medical device that received FDA 510(k) clearance on 2017-03-07. The listed applicant is Isag Rx, Inc.. The 510(k) number is K161865.
When did iSage Rx (iSage Rx Basal Insulin Titration) receive FDA 510(k) clearance?
iSage Rx (iSage Rx Basal Insulin Titration) received FDA 510(k) clearance on 2017-03-07, under 510(k) number K161865.
Who is the listed applicant for iSage Rx (iSage Rx Basal Insulin Titration)?
The FDA 510(k) record lists Isag Rx, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iSage Rx (iSage Rx Basal Insulin Titration)?
The FDA product code for iSage Rx (iSage Rx Basal Insulin Titration) is NDC.
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：NDC）
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。
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