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510(k) K200966

Icare HOME Tonometer by Icare Finland OY — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2020
Date Received
April 10, 2020
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 Icare Finland OY

  • K241447 — iCare ST500 (TA04) (September 27, 2024)
  • K220852 — iCare IC200 (October 6, 2022)
  • K211355 — iCare HOME2 (January 25, 2022)
  • K190316 — Icare ic200 (January 14, 2020)
  • K163343 — Icare HOME tonometer (March 21, 2017)
  • K153694 — Icare ic100 (April 19, 2016)

Other clearances for product code HKY

  • K241447 — iCare ST500 (TA04) (September 27, 2024)
  • K233516 — Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) (May 1, 2024)
  • 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)
  • K190316 — Icare ic200 (January 14, 2020)
  • K191314 — Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q (December 19, 2019)
  • K182491 — Applanation tonometer AT-2 (December 10, 2018)