氧化锆块
K号: K233125 · 2024-01-12
广告
决定日期2024-01-12
产品代码EIH
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
Zirconia Block is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Ivista Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233125. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Zirconia Block?
Zirconia Block is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Hangzhou Ivista Medical Devices Co., Ltd.. The 510(k) number is K233125.
When did Zirconia Block receive FDA 510(k) clearance?
Zirconia Block received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233125.
Who is the listed applicant for Zirconia Block?
The FDA 510(k) record lists Hangzhou Ivista Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zirconia Block?
The FDA product code for Zirconia Block is EIH.
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：EIH）
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