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510(k) K912397

PROFESSIONAL INDIRECT OPHTHALMOSCOPE by Clement Clarke, Inc. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1991
Date Received
May 28, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by Clement Clarke, Inc.

  • K961512 — PERKINS HAND-HELD APPLANATION TONOMETER (July 18, 1996)
  • K952713 — MINI WRIGHT LR AFS (March 29, 1996)
  • K953965 — 904 SLIT LAMP (September 27, 1995)
  • K932258 — OPTICOM M600 (July 25, 1994)
  • K914126 — VMX MINI-LOG FLOWMETER (March 5, 1993)
  • K914896 — FRIEDMANN ANALYSER 3 (January 23, 1992)
  • K895953 — WRIGHT VENTILOMETER VM-1 (February 2, 1990)
  • K841430 — LASERSPEC (December 13, 1984)
  • K781313 — VISION-STIMULATOR, CAM (January 26, 1979)

Other clearances for product code HLI

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  • K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE (September 17, 2014)
  • K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT (April 23, 2014)
  • K131939 — AMICO DH-W35 OPHTHALMOSCOPE SERIES (March 26, 2014)
  • K133892 — IVUE 500 (March 19, 2014)
  • K123316 — HEINE OMEGA 500 (February 26, 2013)
  • K121739 — IVUE WITH NORMATIVE DATABASE (January 18, 2013)
  • K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (May 11, 2012)