SafeAir combi (SFR-combi-US)
K 號：K223932 · 2023-04-26
廣告
器材摘要
SafeAir combi (SFR-combi-US) is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2023-04-26 under 510(k) number K223932. 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 SafeAir combi (SFR-combi-US)?
SafeAir combi (SFR-combi-US) is a medical device that received FDA 510(k) clearance on 2023-04-26. The listed applicant is Lina Medical Aps. The 510(k) number is K223932.
When did SafeAir combi (SFR-combi-US) receive FDA 510(k) clearance?
SafeAir combi (SFR-combi-US) received FDA 510(k) clearance on 2023-04-26, under 510(k) number K223932.
Who is the listed applicant for SafeAir combi (SFR-combi-US)?
The FDA 510(k) record lists Lina Medical Aps as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SafeAir combi (SFR-combi-US)?
The FDA product code for SafeAir combi (SFR-combi-US) 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。
其他以 Lina Medical Aps 為申請人之記錄
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