Oxymag - 运输和紧急呼吸器
K号: K221634 · 2023-05-24
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决定日期2023-05-24
产品代码BTL
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
Oxymag - Transport and Emergency Ventilator is the device name listed in this FDA 510(k) record. The listed applicant is Magnamed Tecnologia Medica S/A. It received FDA 510(k) clearance on 2023-05-24 under 510(k) number K221634. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Oxymag - Transport and Emergency Ventilator?
Oxymag - Transport and Emergency Ventilator is a medical device that received FDA 510(k) clearance on 2023-05-24. The listed applicant is Magnamed Tecnologia Medica S/A. The 510(k) number is K221634.
When did Oxymag - Transport and Emergency Ventilator receive FDA 510(k) clearance?
Oxymag - Transport and Emergency Ventilator received FDA 510(k) clearance on 2023-05-24, under 510(k) number K221634.
Who is the listed applicant for Oxymag - Transport and Emergency Ventilator?
The FDA 510(k) record lists Magnamed Tecnologia Medica S/A as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Oxymag - Transport and Emergency Ventilator?
The FDA product code for Oxymag - Transport and Emergency Ventilator is BTL.
相关临床试验
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相关器械（代码：BTL）
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。
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官方来源
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