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510(k) K844015

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

K844015 is an FDA 510(k) premarket notification submitted by Cns, Inc. for the device "CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE". The FDA issued a decision of Substantially Equivalent on December 17, 1984. The device falls under product code GWS (Analyzer, Spectrum, Electroencephalogram Signal), a Class I device regulated under 21 CFR 882.1420. Cns, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Cns, Inc.

  • K955711 — BREATHE RIGHT NASAL STRIP (May 30, 1996)
  • K954914 — BREATHE RIGHT NASAL STRIP (February 27, 1996)
  • K953772 — BREATHE RIGHT NASAL STRIP (October 20, 1995)
  • K950273 — SLEEP TEST(TM) (September 19, 1995)
  • K921220 — BREATHE RIGHT (October 7, 1993)
  • K912436 — AM-PAK (October 18, 1991)
  • 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)
  • K897107 — POLY G PHYSIOLOGICAL DATA RECORDER (March 12, 1990)

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)

FDA data resources