FDA 510(k)

CATS®-D 视野棱镜

K号: K203850 · 2021-06-14

决定日期2021-06-14

产品代码HKY

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决定实质等同

器械摘要

CATS®-D 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 2021-06-14 under 510(k) number K203850. 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®-D Tonometer Prism?

CATS®-D Tonometer Prism is a medical device that received FDA 510(k) clearance on 2021-06-14. The listed applicant is Cats Tonometer, LLC. The 510(k) number is K203850.

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

CATS®-D Tonometer Prism received FDA 510(k) clearance on 2021-06-14, under 510(k) number K203850.

Who is the listed applicant for CATS®-D 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®-D Tonometer Prism?

The FDA product code for CATS®-D 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™K173904CATS 视野棱镜

官方来源

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