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HKY — Tonometer, Manual Class II

FDA Device Classification

Classification Details

Product Code
HKY
Device Class
Class II
Regulation Number
886.1930
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241447icare finlandiCare ST500 (TA04)September 27, 2024
K233516reichertTono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)May 1, 2024
K234037cats tonometerCATS-L Tonometer™ PrismFebruary 9, 2024
K232143huvitz coApplanation Tonometer HT-5000October 23, 2023
K220852icare finlandiCare IC200October 6, 2022
K211355icare finlandiCare HOME2January 25, 2022
K203850cats tonometerCATS®-D Tonometer PrismJune 14, 2021
K200966icare finlandIcare HOME TonometerMay 7, 2020
K190316icare finlandIcare ic200January 14, 2020
K191314chongqing sunkingdom medical instrument coSunkingdom Applanation Tonometer SK-R, SK-T, SK-QDecember 19, 2019
K182491takagi seiko coApplanation tonometer AT-2December 10, 2018
K180839carl zeiss meditecAT 030June 7, 2018
K173904cats tonometerCATS Tonometer PrismMarch 9, 2018
K172728takagi seiko coApplanation tonometer AT-1October 17, 2017
K163343icare finlandIcare HOME tonometerMarch 21, 2017
K153694icare finlandIcare ic100April 19, 2016
K142263shanghai mediworks precision instruments co.Applanation TonometerApril 15, 2016
K151491falck medicalFalck Medical Multifunction Tonometer, FAT1January 15, 2016
K152644keeler limitedKEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100December 31, 2015
K152308sensor medical technologySensor Medical Single Use Tonometer PrismOctober 13, 2015