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510(k) K822908

COHERENT FUNDUSL RETINAL CAMERA by Coherent Medical Division — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1983
Date Received
September 30, 1982
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 Coherent Medical Division

  • K902990 — COHERENT HOLMIUM:YAG SURGICAL LASER (October 2, 1990)
  • K822415 — THE OCUPLOT D (September 7, 1982)
  • K801906 — DIOPTRON III AUTOREFRACTOR (August 27, 1980)
  • K801336 — MODEL 900K PHOTOCOAGULATOR (July 28, 1980)
  • K791895 — ACCESSORIES FOR SYS. 400 CO2 SURG. LASER (December 20, 1979)

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