Active System; Avenue8
K号: K241395 · 2024-12-18
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决定日期2024-12-18
产品代码ILX
咨询委员会PM
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决定实质等同
器械摘要
Active System; Avenue8 is the device name listed in this FDA 510(k) record. The listed applicant is Caerus Corporation. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K241395. The device is classified under product code ILX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Active System; Avenue8?
Active System; Avenue8 is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Caerus Corporation. The 510(k) number is K241395.
When did Active System; Avenue8 receive FDA 510(k) clearance?
Active System; Avenue8 received FDA 510(k) clearance on 2024-12-18, under 510(k) number K241395.
Who is the listed applicant for Active System; Avenue8?
The FDA 510(k) record lists Caerus Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Active System; Avenue8?
The FDA product code for Active System; Avenue8 is ILX.
相关临床试验
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相关器械（代码：ILX）
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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