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510(k) K142567

RETeval Visual Electrodiagnostic Device by Lkc Technologies, Inc. — Product Code GWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2015
Date Received
September 12, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Photic, Evoked Response
Device Class
Class II
Regulation Number
882.1890
Review Panel
NE
Submission Type

Other clearances by Lkc Technologies, Inc.

  • K914163 — SCOPTOPIC SENSITIVITY TEST-1[SST-1] (October 25, 1991)
  • K913962 — ANOMALOSCOPE QUADRANT TEST-6 (October 23, 1991)
  • K875026 — ANOMALOSCOPE PLATE TEST - 5 [APT-5] (February 5, 1988)
  • K874336 — PATTERN DISCRIMINATION PERIMETER (January 12, 1988)
  • K820414 — UNIVERSAL TESTING & ANALYSIS SYSTEMS (March 4, 1982)
  • K790109 — TELEMETRY, BIOMEDICAL (March 16, 1979)
  • K760199 — ELECTRORETINOGRAPH (August 4, 1976)

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