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510(k) K760199

ELECTRORETINOGRAPH by Lkc Technologies, Inc. — Product Code HLZ

K760199 is an FDA 510(k) premarket notification submitted by Lkc Technologies, Inc. for the device "ELECTRORETINOGRAPH". The FDA issued a decision of Substantially Equivalent on August 4, 1976. The device falls under product code HLZ (Electrode, Corneal), a Class II device regulated under 21 CFR 886.1220. Lkc Technologies, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1976
Date Received
July 7, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Corneal
Device Class
Class II
Regulation Number
886.1220
Review Panel
OP
Submission Type

Other clearances by Lkc Technologies, Inc.

  • K142567 — RETeval Visual Electrodiagnostic Device (May 19, 2015)
  • 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)

Other clearances for product code HLZ

  • K253586 — RM Electrode (RMH 25-01) (April 1, 2026)
  • K232273 — RM Electrode (RMH 23-01) (December 7, 2023)
  • K961805 — TOMEY DTL ELECTRODE (May 9, 1997)
  • K926540 — SOPHER AND BIERER OVUM FORCEPS (February 25, 1994)
  • K913239 — GOLDLENS(TM) (January 31, 1992)
  • K844409 — DTL ELECTRODE (February 14, 1985)
  • K830557 — ERG-JET ELECTRODE (March 31, 1983)
  • K820254 — GOLD FOIL ERG ELECTRODES (April 9, 1982)
  • K813399 — ERG-JET ELECTRODE (January 22, 1982)
  • K781476 — MULAR GOLD LEAF ELECTRODE MODEL 7501 (November 15, 1978)

FDA data resources