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510(k) K851190

NYSTAGMOGRAPH EOG/ENG ANALYSES by Nicolet Biomedical Instruments — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1985
Date Received
March 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nystagmograph
Device Class
Class II
Regulation Number
882.1460
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)
  • K871678 — NICOLET AMP 6R11 SYSTEM (July 16, 1987)
  • K862592 — PHOENIX SYSTEM SEVEN. (September 16, 1986)
  • 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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