我的劑量指導員
K 號：K171230 · 2017-05-26
廣告
器材摘要
My Dose Coach is the device name listed in this FDA 510(k) record. The listed applicant is Sanofi. It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K171230. 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 My Dose Coach?
My Dose Coach is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Sanofi. The 510(k) number is K171230.
When did My Dose Coach receive FDA 510(k) clearance?
My Dose Coach received FDA 510(k) clearance on 2017-05-26, under 510(k) number K171230.
Who is the listed applicant for My Dose Coach?
The FDA 510(k) record lists Sanofi as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for My Dose Coach?
The FDA product code for My Dose Coach 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。
廣告