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510(k) K234037

CATS-L Tonometer™ Prism by Cats Tonometer, LLC — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2024
Date Received
December 21, 2023
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 Cats Tonometer, LLC

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  • K232143 — Applanation Tonometer HT-5000 (October 23, 2023)
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  • 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)
  • K182491 — Applanation tonometer AT-2 (December 10, 2018)