FDA 510(k)

Hudson RCI® 舒適流鼻管預產期、嬰兒；Hudson RCI® 舒適流 Plus 及軟 Plus 鼻管超小號

K 號：K250312 · 2025-07-02

決定日期2025-07-02

產品代碼BTT

諮詢委員會AN

決定相當於

器材摘要

Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250312. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small?

Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Medline Industries, LP. The 510(k) number is K250312.

When did Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small receive FDA 510(k) clearance?

Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250312.

Who is the listed applicant for Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small?

FDA 510(k) 記錄中將 Medline Industries, LP 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small?

The FDA product code for Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small is BTT.