FDA 510(k)

DiaFil Flow

K号: K192284 · 2020-03-25

决定日期2020-03-25

产品代码EBF

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决定实质等同

器械摘要

DiaFil Flow 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 2020-03-25 under 510(k) number K192284. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DiaFil Flow?

DiaFil Flow is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is DiaDent Group International. The 510(k) number is K192284.

When did DiaFil Flow receive FDA 510(k) clearance?

DiaFil Flow received FDA 510(k) clearance on 2020-03-25, under 510(k) number K192284.

Who is the listed applicant for DiaFil Flow?

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 DiaFil Flow?

The FDA product code for DiaFil Flow is EBF.

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。

K254152Dia-X Sil Light Body K254142迪亚-X 硅重体 K261166DIA-CEM K261093DIAFIL K261071DIAFIL 大量流动（经济包装）；DIAFIL 大量流动（补充包装）；DIAFIL 大量流动（0.5g）K254112Dia-X Sil Bite

查看所有 23 个设备 →

官方来源

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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。