Home / 510(k) Clearances / K842612

510(k) K842612

COMPACT AUDITORY by Nicolet Biomedical Instruments — Product Code IKN

K842612 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical Instruments for the device "COMPACT AUDITORY". The FDA issued a decision of Substantially Equivalent on July 20, 1984. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375. Nicolet Biomedical Instruments has at least 10 other 510(k) clearances on record.

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

  • 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)
  • K850108 — EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG (April 11, 1985)
  • K850107 — CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE (April 11, 1985)
  • K843598 — BRAIN FUNCTION MAPPING OPTION FOR PATHF (April 11, 1985)

Other clearances for product code IKN

  • K172743 — Natus VikingQuest (December 19, 2017)
  • K163150 — ViMove2 (July 14, 2017)
  • K162383 — Cadwell Sierra Summit, Cadwell Sierra Ascent (March 1, 2017)
  • K142494 — ViMove (May 28, 2015)
  • K131094 — VIMOVE (July 11, 2014)
  • K123902 — PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) (September 13, 2013)
  • K123399 — MYOVISION 3.0 WIREFREE SYSTEM (August 1, 2013)
  • K113074 — CMAP PRO (February 2, 2012)
  • K102610 — FOCUS EMG DEVICE (March 4, 2011)
  • K110048 — CERSR ELECTROMYOGRAPHY SYSTEM (January 26, 2011)

FDA data resources