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510(k) K152644

KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 by Keeler Limited — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2015
Date Received
September 16, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Manual
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

Other clearances by Keeler Limited

  • K151394 — Keeler Slit Lamp (September 10, 2015)
  • K140451 — KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERI (July 11, 2014)
  • K140450 — KEELER KAPTURE SOFTWARE (June 17, 2014)
  • K133234 — T-TYPE D-KAT, R-TYPE D-KAT (February 21, 2014)

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  • K234037 — CATS-L Tonometer™ Prism (February 9, 2024)
  • K232143 — Applanation Tonometer HT-5000 (October 23, 2023)
  • K220852 — iCare IC200 (October 6, 2022)
  • K211355 — iCare HOME2 (January 25, 2022)
  • K203850 — CATS®-D Tonometer Prism (June 14, 2021)
  • K200966 — Icare HOME Tonometer (May 7, 2020)
  • K190316 — Icare ic200 (January 14, 2020)
  • K191314 — Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q (December 19, 2019)