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510(k) K234037

Device
CATS-L Tonometer? Prism
Applicant
Cats Tonometer, LLC
510(k) number
K234037
Product code
HKY
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-09
Date received
2023-12-21
Regulation
886.1930
Classification name
Tonometer, Manual
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sean McCafferty
Address
1517 N. Wilmot Rd., Suite 143 Tucson AZ US 85712 85712

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HKY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241447iCare ST500 (TA04)Icare Finland OY2024-09-27
K233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.2024-05-01
K232143Applanation Tonometer HT-5000Huvitz Co., Ltd.2023-10-23
K220852iCare IC200Icare Finland OY2022-10-06
K211355iCare HOME2Icare Finland OY2022-01-25
K203850CATS®-D Tonometer PrismCats Tonometer, LLC2021-06-14
K200966Icare HOME TonometerIcare Finland OY2020-05-07
K190316Icare ic200Icare Finland OY2020-01-14
K191314Sunkingdom Applanation Tonometer SK-R, SK-T, SK-QChongqing Sunkingdom Medical Instrument Co., Ltd.2019-12-19
K182491Applanation tonometer AT-2Takagi Seiko Co., Ltd.2018-12-10
K180839AT 030Carl Zeiss Meditec, AG2018-06-07
K173904CATS Tonometer PrismCats Tonometer, LLC2018-03-09
K172728Applanation tonometer AT-1Takagi Seiko Co., Ltd.2017-10-17
K163343Icare HOME tonometerIcare Finland OY2017-03-21
K153694Icare ic100Icare Finland OY2016-04-19