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510(k) K894629

NICOLET BEAM II SYSTEM by Nicolet Instrument Corp. — Product Code GWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1990
Date Received
July 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Spectrum, Electroencephalogram Signal
Device Class
Class I
Regulation Number
882.1420
Review Panel
NE
Submission Type

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  • 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)
  • K896477 — NICOLET REAL EAR ANALYZER (February 8, 1990)
  • K883781 — NICOLET NEUROPORT/ACE SYSTEM (June 5, 1989)
  • K890495 — NICOLET VIKING II SYSTEM (March 16, 1989)
  • K884294 — NICOLET NYSTAR PLUS SYSTEM (November 23, 1988)

Other clearances for product code GWS

  • K974718 — PERSYST PRISM (March 9, 1998)
  • K925735 — EEG ANALYZER (December 3, 1993)
  • K912938 — RHYTHM (July 30, 1991)
  • K871931 — ISTAT SOFTWARE (October 13, 1987)
  • K871480 — STD-228 SPECTRAL TREND DISPLAY (May 1, 1987)
  • K854662 — OEE_7102 EEG/TREND MONITOR (August 20, 1986)
  • K860829 — CNS 4/8 AND CT 48.1 SOFTWARE (May 29, 1986)
  • K854160 — CNS-16 & LTM 1.0 SOFTWARE (January 10, 1986)
  • K850430 — NEUROSCIENCE MAP-10 EEG (July 17, 1985)
  • K844481 — NEUROLAB II (May 20, 1985)