Home / 510(k) Clearances / K052188

510(k) K052188

CUTANEOUS ELECTRODE by Rhythmlink International, LLC — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2005
Date Received
August 11, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Rhythmlink International, LLC

  • K203079 — MR Conditional Sticky Pad Electrode (February 9, 2021)
  • K200984 — Guardian Needle Electrode (May 27, 2020)
  • K191225 — EEG Electrode Template (August 5, 2019)
  • K190801 — PressOn Electrode Headset (July 10, 2019)
  • K172503 — MR Conditional Cup Electrode, MR Conditional Webb Electrode (December 1, 2017)
  • K132138 — RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE (April 11, 2014)
  • K130220 — MR CONDITIONAL PRESSON ELECTRODE (July 22, 2013)
  • K130287 — MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE (May 30, 2013)
  • K121347 — PRESSON ELECTRODE (July 12, 2012)
  • K120342 — EMG RECORDING ELECTRODE ASSEMBLY (June 22, 2012)

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)