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FDA 510(k)

CATS®-D Tonometer Prism

K-Number: K203850 · 2021-06-14

ApplicantCats Tonometer, LLC
Decision Date2021-06-14
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CATS®-D Tonometer Prism is a medical device manufactured by Cats Tonometer, LLC. It received FDA 510(k) clearance on 2021-06-14 under approval number K203850. 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®-D Tonometer Prism?

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

When was CATS®-D Tonometer Prism approved by the FDA?

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

What company makes CATS®-D Tonometer Prism?

CATS®-D Tonometer Prism is manufactured by Cats Tonometer, LLC.

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

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

Other Devices by Cats Tonometer, LLC

K173904CATS Tonometer Prism K234037CATS-L 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

View on FDA Database →

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

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