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510(k) K871678

NICOLET AMP 6R11 SYSTEM by Nicolet Biomedical Instruments — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1987
Date Received
April 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type

Other clearances by Nicolet Biomedical Instruments

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  • K873535 — NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM (October 26, 1987)
  • K862592 — PHOENIX SYSTEM SEVEN. (September 16, 1986)
  • K851190 — NYSTAGMOGRAPH EOG/ENG ANALYSES (November 27, 1985)
  • K850259 — ELECTROENCEPHALOGRAPH EEG (April 11, 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)

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