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510(k) K030297

FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 by Enraf-Nonius, B.V. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2003
Date Received
January 28, 2003
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 Enraf-Nonius, B.V.

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  • K230472 — Sonopuls 190 (October 24, 2023)
  • K151640 — ELTRAC 471 (October 16, 2015)

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)