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FDA 510(k)

Hudson RCI® 4 PSI 压力释放阀的 disposable 加湿器（3230），Hudson RCI® 6 PSI 压力释放阀的 disposable 加湿器（3260）

K号: K230559 · 2023-10-26

申请人Medline Industries, Inc.
决定日期2023-10-26
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® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2023-10-26 under 510(k) number K230559. 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® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)?

Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) is a medical device that received FDA 510(k) clearance on 2023-10-26. The listed applicant is Medline Industries, Inc.. The 510(k) number is K230559.

When did Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) receive FDA 510(k) clearance?

Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) received FDA 510(k) clearance on 2023-10-26, under 510(k) number K230559.

Who is the listed applicant for Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)?

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

What is the FDA product code for Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)?

The FDA product code for Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) is BTT.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Medline Industries, 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。

K223100Hudson RCI AquaTherm III Plus 外部可调电子加热器（050-14）K222665Medline UNITE® 踝关节融合接骨板系统K213054Medline Sure-Snap安全注射针，Medline Sure-Snap安全注射器K212911Konig Mogen 夹K220565Hudson RCI Triflo II 激励深呼吸训练器K213481Medline 普通外科托盘

查看所有 74 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 LimitedK254078HVT 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

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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。

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