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510(k) K132549

ACCUTIP COVER by Accutome, Inc. — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2014
Date Received
August 14, 2013
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 Accutome, Inc.

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  • K050552 — PACHPEN PACHYMETER, MODEL 24-5100 (March 28, 2005)
  • K032956 — ACCUSONIC A-SCAN MODEL, 24-4000 (October 10, 2003)
  • K820050 — KREMER BLADE GAUGE (February 24, 1982)
  • K810660 — KREMER CORNEOMETER ULTRASONIC PACHOMETER (August 21, 1981)

Other clearances for product code HKY

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  • 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)
  • 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)