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510(k) K954781

KOWA GENESIS HAND-HELD FUNDUS CAMERA by Kowa Optimed, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1995
Date Received
October 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

Other clearances by Kowa Optimed, Inc.

  • K013805 — KOWA AUTOMATED TONOMETER KT-500 (October 11, 2002)
  • 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)
  • 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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