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510(k) K002734

ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 by Aspect Medical Systems, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2000
Date Received
September 1, 2000
Clearance Type
Special
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 Aspect Medical Systems, Inc.

  • K093183 — BIS QUATRO SENSOR (October 23, 2009)
  • K091854 — BIS CLICK SENSOR/CABLE (July 2, 2009)
  • K072286 — BIS EEG VISTA MONITOR SYSTEM AND BISX (November 20, 2007)
  • K062613 — BIS EEG MONITOR VIEW (June 18, 2007)
  • K070069 — ZIPPREP ELECTRODE (February 5, 2007)
  • K062692 — BIS BILATERAL SENSOR (December 13, 2006)
  • K052981 — BIS EEG MONITOR, MODEL BISX4 (November 1, 2005)
  • K052362 — BIS EEG MONITOR, MODEL A-3000 (September 9, 2005)
  • K050313 — BIS SRS (SEMI-RESUABLE SENSOR) (February 24, 2005)
  • K041670 — BIS PEDIATRIC SENSOR (July 6, 2004)

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)