AirLife DuoTherm® 加湿系统
K号: K231380 · 2023-08-10
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决定日期2023-08-10
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
AirLife DuoTherm™ Humidification System is the device name listed in this FDA 510(k) record. The listed applicant is Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K231380. 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 AirLife DuoTherm™ Humidification System?
AirLife DuoTherm™ Humidification System is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Vyaire Medical, Inc.. The 510(k) number is K231380.
When did AirLife DuoTherm™ Humidification System receive FDA 510(k) clearance?
AirLife DuoTherm™ Humidification System received FDA 510(k) clearance on 2023-08-10, under 510(k) number K231380.
Who is the listed applicant for AirLife DuoTherm™ Humidification System?
The FDA 510(k) record lists Vyaire Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AirLife DuoTherm™ Humidification System?
The FDA product code for AirLife DuoTherm™ Humidification System 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。
列明Vyaire Medical, 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。
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
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。
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