FDA 510(k)

Hudson RCI® Comfort Flo 鼻导管；Hudson RCI® Comfort Flo Plus 鼻导管

K号: K240163 · 2024-09-27

决定日期2024-09-27

产品代码BTT

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula 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 2024-09-27 under 510(k) number K240163. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula?

Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Medline Industries, LP. The 510(k) number is K240163.

When did Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula receive FDA 510(k) clearance?

Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula received FDA 510(k) clearance on 2024-09-27, under 510(k) number K240163.

Who is the listed applicant for Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula?

FDA 510(k)记录显示Medline Industries, LP为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula?

The FDA product code for Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula is BTT.

列明Medline Industries, LP为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253526NAMIC 扩张器和套管 K254287Medline 可重复使用血压袖带 K253322Hudson RCI® 婴儿Dri-TechTM 呼吸回路（HUD99060 / Dri-Tech 婴儿回路，HUD99060KIT / Dri-Tech 婴儿回路套件，HUD99001KIT / 单肢婴儿回路Dri-Tech 套件，HUD99009KIT / Dri-Tech 婴儿回路套件，HUD99018KIT / Dri-Tech 婴儿回路套件，HUD870NKIT / Dri-Tech 婴儿附件袋，HUD1631 / 婴儿Y型连接器带旋转接头）K251687Konig 贝尔环状包皮环切夹 K253070Namic径向臂带，23厘米（DYNJRADBAND）；Namic径向臂带，26厘米（DYNJRADBANDL）K250345Medline 袋式过滤器

查看所有 31 个设备 →

相关器械（代码：BTT）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262268Optiflow 氧气套件（AA484J）Fisher and Paykel Healthcare Limited K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U 呼吸道加湿器Flexicare Medical Limited.K251419Biogalenic 生物实验室无菌吸入用水，USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ 过滤鼻接口带CO2采样（AA042J）Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo 鼻导管早产儿，婴儿；Hudson RCI® Comfort Flo Plus 和 Soft Plus 鼻导管超小号Medline Industries, LP

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。