FDA 510(k)

CATS-L Tonometer Prism

K-Number: K234037 · 2024-02-09

Decision Date2024-02-09

Product CodeHKY

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

CATS-L Tonometer Prism is a medical device manufactured by Cats Tonometer, LLC. It received FDA 510(k) clearance on 2024-02-09 under approval number K234037. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Cats Tonometer, LLC. The 510(k) number is K234037.

When was CATS-L Tonometer Prism approved by the FDA?

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

What company makes CATS-L Tonometer Prism?

CATS-L Tonometer Prism is manufactured by Cats Tonometer, LLC.

What is the FDA product code for CATS-L Tonometer Prism?

The FDA product code for CATS-L Tonometer Prism is HKY.

Other Devices by Cats Tonometer, LLC

K173904CATS Tonometer Prism K203850CATS®-D Tonometer Prism

Related Devices (Code: HKY)

K153694Icare ic100Icare Finland OY K142263Applanation TonometerShanghai Mediworks Precision Instruments Co. , Ltd. K151491Falck Medical Multifunction Tonometer, FAT1Falck Medical, Inc. K172728Applanation tonometer AT-1Takagi Seiko Co., Ltd. K163343Icare HOME tonometerIcare Finland OY K182491Applanation tonometer AT-2Takagi Seiko Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.