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510(k) K010638

NEUROPLUS, MODEL A10040, A10041, A10042, A10043 by Vermont Medical, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2001
Date Received
March 5, 2001
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 Vermont Medical, Inc.

  • K030073 — VERMED A10021 RESTING EKG TAB ELECTRODE (March 28, 2003)
  • K021537 — MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 (March 3, 2003)
  • K921498 — VER MED A10011 PNS DUAL ELEMENT ELECTRODE (June 9, 1993)
  • K915831 — THERMAL PROBE COVER (June 8, 1992)
  • K911687 — VER-MED A10020 RESTING EKG ELECTRODE (October 10, 1991)
  • K910139 — VER-MED A10014 RESTING EKG ELECTRODE & A10021 (August 15, 1991)
  • K905489 — VER-MED A10017 UNIVERSAL ELECTRODE (March 21, 1991)
  • K781430 — PREGELLED DISPOSABLE E.K.G. ELECTRODE (October 31, 1978)

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)