DIA-CEM
K号: K261166 · 2026-07-09
广告
决定日期2026-07-09
产品代码EMA
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
DIA-CEM is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2026-07-09 under 510(k) number K261166. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DIA-CEM?
DIA-CEM is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is DiaDent Group International. The 510(k) number is K261166.
When did DIA-CEM receive FDA 510(k) clearance?
DIA-CEM received FDA 510(k) clearance on 2026-07-09, under 510(k) number K261166.
Who is the listed applicant for DIA-CEM?
FDA 510(k)记录显示DiaDent Group International为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for DIA-CEM?
The FDA product code for DIA-CEM is EMA.
列明DiaDent Group International为申报人的其他记录
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：EMA）
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