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510(k) K800001

MINI-CEARS COMPUTER (MODEL 1) by Bik Foundation, Inc. — Product Code GWS

K800001 is an FDA 510(k) premarket notification submitted by Bik Foundation, Inc. for the device "MINI-CEARS COMPUTER (MODEL 1)". The FDA issued a decision of Substantially Equivalent on January 31, 1980. The device falls under product code GWS (Analyzer, Spectrum, Electroencephalogram Signal), a Class I device regulated under 21 CFR 882.1420.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1980
Date Received
January 2, 1980
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 for product code GWS

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  • 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