INOmax DSIR Plus
K号: K200389 · 2020-06-17
广告
决定日期2020-06-17
产品代码MRN
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
INOmax DSIR Plus is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Manufacturing, LLC. It received FDA 510(k) clearance on 2020-06-17 under 510(k) number K200389. The device is classified under product code MRN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the INOmax DSIR Plus?
INOmax DSIR Plus is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Mallinckrodt Manufacturing, LLC. The 510(k) number is K200389.
When did INOmax DSIR Plus receive FDA 510(k) clearance?
INOmax DSIR Plus received FDA 510(k) clearance on 2020-06-17, under 510(k) number K200389.
Who is the listed applicant for INOmax DSIR Plus?
The FDA 510(k) record lists Mallinckrodt Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for INOmax DSIR Plus?
The FDA product code for INOmax DSIR Plus is MRN.
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Mallinckrodt Manufacturing, LLC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：MRN）
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。
K242374ULSPIRA TS™ 一氧化氮治疗系统Airgas Therapeutics, LLCK242578EVOLVE 氧化氮输送系统Mallinckrodt Manufacturing, LLCK240410EVOLVE 氧化氮输送系统Malinckrodt Manufacturing, LLCK233251NOxBOXi 一氧化氮输送系统Linde Gas & Equipment, Inc.K222930Evolve 氧化亚氮输送系统Mallinckrodt Manufacturing, LLCK231823NOxBOXi 一氧化氮输送系统Linde Gas & Equipment, Inc.
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。
广告