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510(k) K844481

NEUROLAB II by Teca, Inc. — Product Code GWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1985
Date Received
November 19, 1984
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

Other clearances by Teca, Inc.

  • K962283 — EEG ELECTRODES (December 16, 1996)
  • K903731 — SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME (February 4, 1991)
  • K903004 — EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH (November 15, 1990)
  • K896666 — P460, DG32 ELECTROENCEPHALOGRAPH (February 16, 1990)
  • K894889 — TECA NEUROMAPPER 386 (December 22, 1989)
  • K894088 — TECA NEUROMAPPER 1620, BRAIN MAPPER (November 15, 1989)
  • K890881 — TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS (March 23, 1989)
  • K884870 — TECA/MEDELEC 'CONCEPT' P420 (February 23, 1989)
  • K880593 — TECA/MEDELEC MISTRAL (April 6, 1988)
  • K872931 — TECA/MEDELEC TTT THERMAL THRESHOLD TESTER (November 16, 1987)

Other clearances for product code GWS

  • K974718 — PERSYST PRISM (March 9, 1998)
  • K925735 — EEG ANALYZER (December 3, 1993)
  • K912938 — RHYTHM (July 30, 1991)
  • K894629 — NICOLET BEAM II SYSTEM (March 9, 1990)
  • 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)