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510(k) K850108

EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG by Nicolet Biomedical Instruments — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1985
Date Received
January 10, 1985
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 Nicolet Biomedical Instruments

  • K880573 — MODIFIED NICOLET VIKING SYSTEM (March 22, 1988)
  • K873736 — NICOLET DIGITAL TWO PIECE HEARING AID (December 8, 1987)
  • K873964 — NICOLET DISPOSABLE PRASS PROBE (November 20, 1987)
  • K873535 — NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM (October 26, 1987)
  • K871678 — NICOLET AMP 6R11 SYSTEM (July 16, 1987)
  • K862592 — PHOENIX SYSTEM SEVEN. (September 16, 1986)
  • K851190 — NYSTAGMOGRAPH EOG/ENG ANALYSES (November 27, 1985)
  • K843598 — BRAIN FUNCTION MAPPING OPTION FOR PATHF (April 11, 1985)
  • K850107 — CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE (April 11, 1985)
  • K850259 — ELECTROENCEPHALOGRAPH EEG (April 11, 1985)

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  • K243788 — IceCap product line (March 13, 2025)
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  • K241160 — CAIs Sensor (CAIs-001) (December 13, 2024)
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