ICX-植入系统
K号: K231566 · 2024-09-05
广告
决定日期2024-09-05
产品代码DZE
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同
器械摘要
ICX-Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Medentis Medical GmbH. It received FDA 510(k) clearance on 2024-09-05 under 510(k) number K231566. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ICX-Implant System?
ICX-Implant System is a medical device that received FDA 510(k) clearance on 2024-09-05. The listed applicant is Medentis Medical GmbH. The 510(k) number is K231566.
When did ICX-Implant System receive FDA 510(k) clearance?
ICX-Implant System received FDA 510(k) clearance on 2024-09-05, under 510(k) number K231566.
Who is the listed applicant for ICX-Implant System?
The FDA 510(k) record lists Medentis Medical GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ICX-Implant System?
The FDA product code for ICX-Implant System is DZE.
相关临床试验
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。
相关器械（代码：DZE）
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。
广告