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510(k) K013805

KOWA AUTOMATED TONOMETER KT-500 by Kowa Optimed, Inc. — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2002
Date Received
November 15, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

Other clearances by Kowa Optimed, Inc.

  • K961090 — AUTOMATIC VISUAL FIELD PLOTTER AP-125 (June 17, 1996)
  • K960924 — KOWA HAND-HELD APPLANATION TONOMETER HA-1 (June 4, 1996)
  • K955442 — KOWA SC-1200 PHOTO SLIT LAMP SYSTEM (January 3, 1996)
  • K954780 — KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C (December 1, 1995)
  • K954781 — KOWA GENESIS HAND-HELD FUNDUS CAMERA (December 1, 1995)
  • K954782 — KOWA PORTABLE SLIT LAMP SL-14 & SL-14B (November 24, 1995)
  • K913852 — LASER FLARE METER (February 7, 1992)
  • K880920 — LASER FLARE CELL METER FC-1000 (September 27, 1988)
  • K881219 — AUTOMATIC PERIMETER, AP-340 (May 3, 1988)

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