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510(k) K880573

MODIFIED NICOLET VIKING SYSTEM by Nicolet Biomedical Instruments — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1988
Date Received
February 10, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type

Other clearances by Nicolet Biomedical Instruments

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  • 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)
  • K850108 — EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG (April 11, 1985)
  • K850259 — ELECTROENCEPHALOGRAPH EEG (April 11, 1985)

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