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510(k) K844015

CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE by Cns, Inc. — Product Code GWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1984
Date Received
October 12, 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

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  • K904432 — SLEEP I/T-5 AND SLEEP I/T-8 (July 10, 1991)
  • K910452 — RESPI-PAK RT-PAK (April 16, 1991)
  • K901549 — CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE. (October 24, 1990)
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Other clearances for product code GWS

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  • 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)