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510(k) K813399

ERG-JET ELECTRODE by Nicolet Biomedical Instruments — Product Code HLZ

K813399 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical Instruments for the device "ERG-JET ELECTRODE". The FDA issued a decision of Substantially Equivalent on January 22, 1982. The device falls under product code HLZ (Electrode, Corneal), a Class II device regulated under 21 CFR 886.1220. Nicolet Biomedical Instruments has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1982
Date Received
December 4, 1981
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 Nicolet Biomedical Instruments

  • K880573 — MODIFIED NICOLET VIKING SYSTEM (March 22, 1988)
  • K873736 — NICOLET DIGITAL TWO PIECE HEARING AID (December 8, 1987)
  • K873964 — NICOLET DISPOSABLE PRASS PROBE (November 20, 1987)
  • K873535 — NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM (October 26, 1987)
  • K871678 — NICOLET AMP 6R11 SYSTEM (July 16, 1987)
  • K862592 — PHOENIX SYSTEM SEVEN. (September 16, 1986)
  • K851190 — NYSTAGMOGRAPH EOG/ENG ANALYSES (November 27, 1985)
  • K843598 — BRAIN FUNCTION MAPPING OPTION FOR PATHF (April 11, 1985)
  • K850107 — CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE (April 11, 1985)
  • K850108 — EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG (April 11, 1985)

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)
  • K781476 — MULAR GOLD LEAF ELECTRODE MODEL 7501 (November 15, 1978)
  • K760199 — ELECTRORETINOGRAPH (August 4, 1976)

FDA data resources