智滴
K 號:K251598 · 2025-12-10
廣告
器材摘要
Intellidrop is the device name listed in this FDA 510(k) record. The listed applicant is Brainspace, Inc.. It received FDA 510(k) clearance on 2025-12-10 under 510(k) number K251598. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Intellidrop?
Intellidrop is a medical device that received FDA 510(k) clearance on 2025-12-10. The listed applicant is Brainspace, Inc.. The 510(k) number is K251598.
When did Intellidrop receive FDA 510(k) clearance?
Intellidrop received FDA 510(k) clearance on 2025-12-10, under 510(k) number K251598.
Who is the listed applicant for Intellidrop?
The FDA 510(k) record lists Brainspace, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Intellidrop?
The FDA product code for Intellidrop is JXG.
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:JXG)
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。
K261004Codman® 遠端腹膜針管,铍白開口型(82-1682);Codman® HOLTER® 腹膜針管(SALMON設計)(82-1684)Integra Lifesciences Production CorporationK250636Sophy Mini 單壓力閥 (SM1)SophysaK252514EVAC-MRIPhasor Health, LLCK243531科德曼Libertís分流針管搭配Bactiseal及Endexo技術Integra Lifesciences Production CorporationK243552Codman Libertís™ 1.5 mm EVD 腔管,配備 Bactiseal® 及 Endexo® 技術,並具有 Luer 接頭(821761);Codman Libertís™ 1.9 mm EVD 腔管,配備 Bactiseal® 及 Endexo® 技術,並具有 Luer 接頭(821762)Integra Lifesciences Production CorporationK242974外部CSF引流室內針管,外部CSF引流腰推針管Sophysa
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