D-LUX+
K号: K200809 · 2020-08-07
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决定日期2020-08-07
产品代码EBZ
咨询委员会DE
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决定实质等同
器械摘要
D-LUX+ 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 2020-08-07 under 510(k) number K200809. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the D-LUX+?
D-LUX+ is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is DiaDent Group International. The 510(k) number is K200809.
When did D-LUX+ receive FDA 510(k) clearance?
D-LUX+ received FDA 510(k) clearance on 2020-08-07, under 510(k) number K200809.
Who is the listed applicant for D-LUX+?
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 D-LUX+?
The FDA product code for D-LUX+ is EBZ.
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：EBZ）
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。
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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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