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510(k) K924760

TOMEY PROTON TONOMETER by Tomey Corporation USA — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1993
Date Received
September 23, 1992
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 Tomey Corporation USA

  • K971953 — CONFOSCAN (August 14, 1997)
  • K971685 — IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM (June 24, 1997)
  • K961805 — TOMEY DTL ELECTRODE (May 9, 1997)
  • K932571 — TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 (August 31, 1995)
  • K945959 — VIDEO VISION ANALYZER (VIVA), VRB 100 (March 1, 1995)
  • K944910 — TOMEY EM-1000 SPECULAR MICROSCOPE (November 22, 1994)
  • K921815 — TOMEY PE-300 PORTABLE ERG (July 15, 1992)
  • K912112 — PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 (June 17, 1991)

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  • K191314 — Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q (December 19, 2019)