FAgamin®
K号: K240059 · 2024-05-16
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申请人Tedequim Srl
决定日期2024-05-16
产品代码PHR
咨询委员会DE
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决定实质等同
器械摘要
FAgamin® is the device name listed in this FDA 510(k) record. The listed applicant is Tedequim Srl. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K240059. The device is classified under product code PHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the FAgamin®?
FAgamin® is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Tedequim Srl. The 510(k) number is K240059.
When did FAgamin® receive FDA 510(k) clearance?
FAgamin® received FDA 510(k) clearance on 2024-05-16, under 510(k) number K240059.
Who is the listed applicant for FAgamin®?
The FDA 510(k) record lists Tedequim Srl as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FAgamin®?
The FDA product code for FAgamin® is PHR.
相关临床试验
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相关器械（代码：PHR）
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。
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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