FlowStar 触摸数字混合流量计
K号: K222794 · 2023-07-28
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决定日期2023-07-28
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
FlowStar Touch Digital Mixer Flowmeter is the device name listed in this FDA 510(k) record. The listed applicant is Baldus Sedation GmbH & Co. KG. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K222794. 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 FlowStar Touch Digital Mixer Flowmeter?
FlowStar Touch Digital Mixer Flowmeter is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Baldus Sedation GmbH & Co. KG. The 510(k) number is K222794.
When did FlowStar Touch Digital Mixer Flowmeter receive FDA 510(k) clearance?
FlowStar Touch Digital Mixer Flowmeter received FDA 510(k) clearance on 2023-07-28, under 510(k) number K222794.
Who is the listed applicant for FlowStar Touch Digital Mixer Flowmeter?
The FDA 510(k) record lists Baldus Sedation GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FlowStar Touch Digital Mixer Flowmeter?
The FDA product code for FlowStar Touch Digital Mixer Flowmeter 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。
列明Baldus Sedation GmbH & Co. KG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：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. KGK221494Quality Mix Blender, OxymixerDehas Medical Systems GmbHK202480Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin
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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