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510(k) K842612

COMPACT AUDITORY by Nicolet Biomedical Instruments — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1984
Date Received
July 5, 1984
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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  • K843598 — BRAIN FUNCTION MAPPING OPTION FOR PATHF (April 11, 1985)
  • K850107 — CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE (April 11, 1985)

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