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510(k) K820254

GOLD FOIL ERG ELECTRODES by Cadwell Laboratories, Inc. — Product Code HLZ

K820254 is an FDA 510(k) premarket notification submitted by Cadwell Laboratories, Inc. for the device "GOLD FOIL ERG ELECTRODES". The FDA issued a decision of Substantially Equivalent on April 9, 1982. The device falls under product code HLZ (Electrode, Corneal), a Class II device regulated under 21 CFR 886.1220. Cadwell Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1982
Date Received
February 1, 1982
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 Cadwell Laboratories, Inc.

  • K061706 — CADWELL EASYNET OXIMETER MODULE (March 5, 2007)
  • K061705 — CADWELL EASYNET NASAL PRESSURE MODULE (November 21, 2006)
  • K042350 — TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR (November 3, 2004)
  • K040986 — CADWELL LIMB MOVEMENT MODULE (July 1, 2004)
  • K040932 — EASYNET BODY POSITION MODULE (July 1, 2004)
  • K971214 — KILOWIN (June 11, 1998)
  • K962458 — CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962457 — TWO-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962455 — FOUR-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K946094 — CADWELL EASY AMBULATORY EEG (September 12, 1995)

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)
  • K813399 — ERG-JET ELECTRODE (January 22, 1982)
  • K781476 — MULAR GOLD LEAF ELECTRODE MODEL 7501 (November 15, 1978)
  • K760199 — ELECTRORETINOGRAPH (August 4, 1976)

FDA data resources