FDA 510(k)

CATS 视野棱镜

K号: K173904 · 2018-03-09

决定日期2018-03-09

产品代码HKY

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决定实质等同

器械摘要

CATS Tonometer Prism is the device name listed in this FDA 510(k) record. The listed applicant is Cats Tonometer, LLC. It received FDA 510(k) clearance on 2018-03-09 under 510(k) number K173904. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CATS Tonometer Prism?

CATS Tonometer Prism is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Cats Tonometer, LLC. The 510(k) number is K173904.

When did CATS Tonometer Prism receive FDA 510(k) clearance?

CATS Tonometer Prism received FDA 510(k) clearance on 2018-03-09, under 510(k) number K173904.

Who is the listed applicant for CATS Tonometer Prism?

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

What is the FDA product code for CATS Tonometer Prism?

The FDA product code for CATS Tonometer Prism is HKY.

列明Cats Tonometer, 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。

K234037CATS-L 视野棱镜™K203850CATS®-D 视野棱镜

官方来源

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