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510(k) K862377

QMED SELF ADHERING ELECTRODE by Qmed, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1986
Date Received
June 24, 1986
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 Qmed, Inc.

  • K972991 — MONITOR ONE NDX (December 3, 1998)
  • K932109 — PROFILOMAT (December 3, 1993)
  • K921476 — INTERP-1000 (October 21, 1992)
  • K897121 — QEKG ELECTROCARDIOGRAPH (April 30, 1990)
  • K873591 — A.R.M. (ASPEN RETURN MONITOR) (September 30, 1987)
  • K863091 — BICORD BY QMED (August 29, 1986)
  • K861437 — QMED SYSTEM 2150 (May 20, 1986)
  • K843559 — KLEENIT BY QMED (October 24, 1984)
  • K841172 — MONITOR ONE (July 27, 1984)
  • K840465 — Q-MED ELECTRODE (June 19, 1984)

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  • 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)