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510(k) K832996

SURGICAL IOP MONITOR by Miami Eye Technology, Inc. — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1983
Date Received
September 2, 1983
Clearance Type
Traditional
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 Miami Eye Technology, Inc.

  • K841101 — CLAYMAN-PAREL CAPSULE COUPEUR (May 16, 1984)
  • K832912 — GELENDER VACUUM FIXATION RING SYS (January 10, 1984)
  • K832997 — EPA AUTOMATED INFUSION POLE (October 4, 1983)
  • K832911 — ABBOTT GLOBE HOLDER (September 29, 1983)
  • K831702 — RARE-EARTH INTRA-OCULAR MAGNET (June 30, 1983)

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  • K232143 — Applanation Tonometer HT-5000 (October 23, 2023)
  • K220852 — iCare IC200 (October 6, 2022)
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  • 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)