即速風扇
K 號：K251542 · 2025-07-18
廣告
器材摘要
InstaFAN is the device name listed in this FDA 510(k) record. The listed applicant is Onepass Medical , Ltd.. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K251542. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the InstaFAN?
InstaFAN is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Onepass Medical , Ltd.. The 510(k) number is K251542.
When did InstaFAN receive FDA 510(k) clearance?
InstaFAN received FDA 510(k) clearance on 2025-07-18, under 510(k) number K251542.
Who is the listed applicant for InstaFAN?
The FDA 510(k) record lists Onepass Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for InstaFAN?
The FDA product code for InstaFAN is ODG.
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：ODG）
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。
K261183EVIS EUS 超聲波胃腸內視鏡 (Olympus GF-UE190)Olympus Medical Systems CorporationK260428RIVOS™ EUS進入設備（M00553900）Boston Scientific CorporationK251859EVIS EUS 超聲波胃腸內視鏡 (Olympus GF-UE190)Olympus Medical Systems CorporationK231813超音波胃視鏡Sonoscape Medical Corp.K232518EndoSound視覺系統；EVSEndosound, Inc.K223616Acquire™ S內視鏡超聲針吸細胞檢查（FNB）設備Boston Scientific Corporation
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