EOlife®
K号: K221841 · 2023-03-18
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申请人Archeon
决定日期2023-03-18
产品代码BTM
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
EOlife® is the device name listed in this FDA 510(k) record. The listed applicant is Archeon. It received FDA 510(k) clearance on 2023-03-18 under 510(k) number K221841. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EOlife®?
EOlife® is a medical device that received FDA 510(k) clearance on 2023-03-18. The listed applicant is Archeon. The 510(k) number is K221841.
When did EOlife® receive FDA 510(k) clearance?
EOlife® received FDA 510(k) clearance on 2023-03-18, under 510(k) number K221841.
Who is the listed applicant for EOlife®?
The FDA 510(k) record lists Archeon as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EOlife®?
The FDA product code for EOlife® is BTM.
相关临床试验
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相关器械（代码：BTM）
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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