Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
K号: K202480 · 2021-04-22
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决定日期2021-04-22
产品代码BZR
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
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 is the device name listed in this FDA 510(k) record. The listed applicant is Parker Hannifin. It received FDA 510(k) clearance on 2021-04-22 under 510(k) number K202480. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50?
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 is a medical device that received FDA 510(k) clearance on 2021-04-22. The listed applicant is Parker Hannifin. The 510(k) number is K202480.
When did Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 receive FDA 510(k) clearance?
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 received FDA 510(k) clearance on 2021-04-22, under 510(k) number K202480.
Who is the listed applicant for Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50?
The FDA 510(k) record lists Parker Hannifin as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50?
The FDA product code for Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 is BZR.
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。
相关器械（代码：BZR）
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。
K243917F&P Optiflow空气/氧气流量源Fisher & Paykel Healthcare, Ltd.K241465Midas 流量计；eAVSParker Hannifin CorporationK231895Maxtec MaxBlend2+pMaxtec, LLCK230987FlowStar 模拟混合流量计Baldus Sedation GmbH & Co. KGK222794FlowStar 触摸数字混合流量计Baldus Sedation GmbH & Co. KGK221494Quality Mix Blender, OxymixerDehas Medical Systems GmbH
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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