FMX314 外科平台
K 號：K160797 · 2016-08-26
廣告
器材摘要
FMX314 Surgical Platform is the device name listed in this FDA 510(k) record. The listed applicant is Fortimedix Surgical B.V.. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K160797. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FMX314 Surgical Platform?
FMX314 Surgical Platform is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Fortimedix Surgical B.V.. The 510(k) number is K160797.
When did FMX314 Surgical Platform receive FDA 510(k) clearance?
FMX314 Surgical Platform received FDA 510(k) clearance on 2016-08-26, under 510(k) number K160797.
Who is the listed applicant for FMX314 Surgical Platform?
The FDA 510(k) record lists Fortimedix Surgical B.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FMX314 Surgical Platform?
The FDA product code for FMX314 Surgical Platform is OTJ.
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：OTJ）
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