FDA 510(k)

十进制3D

K号: K192554 · 2019-12-13

决定日期2019-12-13

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

decimal3D is the device name listed in this FDA 510(k) record. The listed applicant is .Decimal, LLC. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K192554. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the decimal3D?

decimal3D is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is .Decimal, LLC. The 510(k) number is K192554.

When did decimal3D receive FDA 510(k) clearance?

decimal3D received FDA 510(k) clearance on 2019-12-13, under 510(k) number K192554.

Who is the listed applicant for decimal3D?

The FDA 510(k) record lists .Decimal, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for decimal3D?

The FDA product code for decimal3D is MUJ.

列明.Decimal, LLC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。

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