Home / 510(k) Clearances / K890495

510(k) K890495

NICOLET VIKING II SYSTEM by Nicolet Instrument Corp. — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1989
Date Received
February 1, 1989
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 Instrument Corp.

  • K921138 — NICOLET ULTRASOM ACQUISITION STATION (May 14, 1993)
  • K923315 — NICOLET ARK SYSTEM (November 23, 1992)
  • K921927 — NICOLET VOYAGEUR (November 5, 1992)
  • K915652 — NICOLET PORATBLE SPIRIT SYSTEM (February 7, 1992)
  • K905632 — NICOLET MAPLELEAF SYSTEM (June 7, 1991)
  • K897154 — NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE (April 30, 1990)
  • K894629 — NICOLET BEAM II SYSTEM (March 9, 1990)
  • K896477 — NICOLET REAL EAR ANALYZER (February 8, 1990)
  • K883781 — NICOLET NEUROPORT/ACE SYSTEM (June 5, 1989)
  • K884294 — NICOLET NYSTAR PLUS SYSTEM (November 23, 1988)

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)