FDA 510(k)

Hudson RCI Variable浓度大容量雾化器（1770）

K号: K220955 · 2023-06-23

决定日期2023-06-23

产品代码CAF

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决定实质等同

器械摘要

Hudson RCI Variable concentration Large Volume Nebulizer (1770) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industires, Inc.. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K220955. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hudson RCI Variable concentration Large Volume Nebulizer (1770)?

Hudson RCI Variable concentration Large Volume Nebulizer (1770) is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Medline Industires, Inc.. The 510(k) number is K220955.

When did Hudson RCI Variable concentration Large Volume Nebulizer (1770) receive FDA 510(k) clearance?

Hudson RCI Variable concentration Large Volume Nebulizer (1770) received FDA 510(k) clearance on 2023-06-23, under 510(k) number K220955.

Who is the listed applicant for Hudson RCI Variable concentration Large Volume Nebulizer (1770)?

The FDA 510(k) record lists Medline Industires, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hudson RCI Variable concentration Large Volume Nebulizer (1770)?

The FDA product code for Hudson RCI Variable concentration Large Volume Nebulizer (1770) is CAF.

列明Medline Industires, Inc.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。

K201129Medline 烟雾抽吸笔 K201390Medline 粉末-free 浅蓝色硅橡胶检查手套（经测试可用于化疗药物）K200960Medline 粉末-free 检查手套（经测试可用于化疗药物）K201319Medline UNITE Jones骨折螺钉系统

相关器械（代码：CAF）

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。

K254171网状雾化器（UN204）；网状雾化器（UN205）；网状雾化器（UN209）；网状雾化器（UN210）Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE 用于 pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid带eTrack系统Pari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035便携式网状雾化器（JM821）Shenzhen Jermei Medical Device Technology Co., Ltd.K243468压缩机雾化器（NB-1100）；压缩机雾化器（NB-1101）；压缩机雾化器（NB-1102）；压缩机雾化器（NB-1103）Joytech Healthcare Co. , Ltd.

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