FDA 510(k)

EM-4000 显微镜

K号: K171313 · 2018-01-19

决定日期2018-01-19

产品代码NQE

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决定实质等同

器械摘要

EM-4000 Specular Microscope is the device name listed in this FDA 510(k) record. The listed applicant is Tomey Corporation. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K171313. The device is classified under product code NQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EM-4000 Specular Microscope?

EM-4000 Specular Microscope is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Tomey Corporation. The 510(k) number is K171313.

When did EM-4000 Specular Microscope receive FDA 510(k) clearance?

EM-4000 Specular Microscope received FDA 510(k) clearance on 2018-01-19, under 510(k) number K171313.

Who is the listed applicant for EM-4000 Specular Microscope?

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

What is the FDA product code for EM-4000 Specular Microscope?

The FDA product code for EM-4000 Specular Microscope is NQE.

列明Tomey Corporation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。

K252348Tomey 光学生物测量仪 OA-2000（OA-2000）K250553Tomey 角膜/眼前节光学相干断层扫描仪（CASIA2）K213265Tomey 角膜/眼前节光学相干断层扫描仪 CASIA2

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。