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510(k) K925735

EEG ANALYZER by Bio-Scan, Inc. — Product Code GWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1993
Date Received
November 13, 1992
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 Bio-Scan, Inc.

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Other clearances for product code GWS

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  • 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)
  • K844481 — NEUROLAB II (May 20, 1985)