Hidroxa SE30
K号: K241267 · 2024-10-17
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决定日期2024-10-17
产品代码EGJ
咨询委员会PM
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决定实质等同
器械摘要
Hidroxa SE30 is the device name listed in this FDA 510(k) record. The listed applicant is Hidroxa Medical AB. It received FDA 510(k) clearance on 2024-10-17 under 510(k) number K241267. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Hidroxa SE30?
Hidroxa SE30 is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Hidroxa Medical AB. The 510(k) number is K241267.
When did Hidroxa SE30 receive FDA 510(k) clearance?
Hidroxa SE30 received FDA 510(k) clearance on 2024-10-17, under 510(k) number K241267.
Who is the listed applicant for Hidroxa SE30?
The FDA 510(k) record lists Hidroxa Medical AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hidroxa SE30?
The FDA product code for Hidroxa SE30 is EGJ.
相关临床试验
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相关器械（代码：EGJ）
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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