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510(k) K854662

OEE_7102 EEG/TREND MONITOR by Nihon Kohden America, Inc. — Product Code GWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1986
Date Received
November 20, 1985
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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Other clearances for product code GWS

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  • K894629 — NICOLET BEAM II SYSTEM (March 9, 1990)
  • K871931 — ISTAT SOFTWARE (October 13, 1987)
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  • 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)