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510(k) K110223

WAVEGUARD (TM) EEG CAP by Eemagine Medical Imaging Solutions GmbH — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2011
Date Received
January 25, 2011
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 Eemagine Medical Imaging Solutions GmbH

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  • K192889 — Neo (January 30, 2020)
  • K172312 — eego amplifiers (March 30, 2018)
  • K070358 — MAXINSIGHT (July 30, 2007)
  • K051825 — COGNITRACE (September 12, 2005)
  • K002631 — ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG (October 23, 2000)

Other clearances for product code GXY

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  • 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)