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510(k) K142179

D-KAT Z-YPE by Keeler, Ltd. — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2014
Date Received
August 8, 2014
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, Ltd.

  • K131787 — CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES (December 23, 2013)
  • K131589 — KEELER SLIT LAMP H-SERIES (June 27, 2013)
  • K093445 — KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) (January 19, 2010)

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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)