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510(k) K021986

BRAINET by Nicolet Biomedical, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2002
Date Received
June 18, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

Other clearances by Nicolet Biomedical, Inc.

  • K020754 — NICOLET PIONEER TC8080 (April 21, 2003)
  • K021144 — SUBDURAL STRIP ELECTRODE (June 24, 2002)
  • K020218 — SNAP EEG MONITOR (April 22, 2002)
  • K013281 — VERSALAB APM (April 18, 2002)
  • K020955 — NICOLET ELECTROCAUTERY DETECTOR (April 17, 2002)
  • K013419 — NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM (December 20, 2001)
  • K011823 — BIOREHAB SYSTEM (September 6, 2001)
  • K011818 — STERILE EMG ELECTRODES (September 6, 2001)
  • K011135 — GSI AUDERA (July 26, 2001)
  • K010019 — STERILE SUBDERMAL NEEDLE ELECTRODES (March 19, 2001)

Other clearances for product code GXY

  • K260453 — Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (March 12, 2026)
  • K254033 — Ceribell Instant EEG Headset (February 9, 2026)
  • K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (October 31, 2025)
  • K250841 — Electrotherapy Electrodes (August 13, 2025)
  • K243788 — IceCap product line (March 13, 2025)
  • K243243 — Delphi MCS Electrode Cap (February 6, 2025)
  • K241512 — Electrode Pad (January 15, 2025)
  • K242326 — Wave Electrode (AE02-60); Wave Electrode (AE02-50) (January 2, 2025)
  • K241160 — CAIs Sensor (CAIs-001) (December 13, 2024)
  • K240575 — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (November 25, 2024)