FDA 510(k)

CATS-L 视野棱镜™

K号: K234037 · 2024-02-09

决定日期2024-02-09

产品代码HKY

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决定实质等同

器械摘要

CATS-L 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 2024-02-09 under 510(k) number K234037. 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-L Tonometer™ Prism?

CATS-L Tonometer™ Prism is a medical device that received FDA 510(k) clearance on 2024-02-09. The listed applicant is Cats Tonometer, LLC. The 510(k) number is K234037.

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

CATS-L Tonometer™ Prism received FDA 510(k) clearance on 2024-02-09, under 510(k) number K234037.

Who is the listed applicant for CATS-L 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-L Tonometer™ Prism?

The FDA product code for CATS-L 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。

K203850CATS®-D 视野棱镜 K173904CATS 视野棱镜

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