Dia-Cem
K号: K231552 · 2023-07-28
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决定日期2023-07-28
产品代码EMA
咨询委员会DE
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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 2023-07-28 under 510(k) number K231552. 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 2023-07-28. The listed applicant is DiaDent Group International. The 510(k) number is K231552.
When did Dia-Cem receive FDA 510(k) clearance?
Dia-Cem received FDA 510(k) clearance on 2023-07-28, under 510(k) number K231552.
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。
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