DEX 裝置
K 號：K191878 · 2021-01-29
廣告
器材摘要
DEX Device is the device name listed in this FDA 510(k) record. The listed applicant is Dex Surgical. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K191878. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DEX Device?
DEX Device is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Dex Surgical. The 510(k) number is K191878.
When did DEX Device receive FDA 510(k) clearance?
DEX Device received FDA 510(k) clearance on 2021-01-29, under 510(k) number K191878.
Who is the listed applicant for DEX Device?
The FDA 510(k) record lists Dex Surgical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DEX Device?
The FDA product code for DEX Device is GEI.
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：GEI）
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。
K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLCK261959Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，70mm刀片，按鈕開關（0703-046-100）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，按鈕開關，大量非無菌（0703-046-102）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，70mm刀片， rocking 開關（0703-047-100）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，rocking 開關，大量非無菌（0703-047-102）Stryker InstrumentsK261070LigaSure™ RAS 馬里蘭 頰部 血管 黏合器/分離器，納米塗層Covidien, LLCK254185波坦茲·普瑞美Jeisys Medical IncorporatedK262364艾利安恩尼格瑪雷射設備Ellian CorpK253859紅色專業版（Scarlet Pro）VIOL Co., Ltd.
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