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510(k) K063797

GEODESIC EEG SYSTEM 300 by Electrical Geodesics, Incorporated — Product Code OLT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2007
Date Received
December 22, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Normalizing Quantitative Electroencephalograph Software
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.

Other clearances by Electrical Geodesics, Incorporated

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  • K033399 — GEODESIC EEG SYSTEM SERIES 100 (August 4, 2004)
  • K012079 — GEODESIC EEG SYSTEM, MODEL 200 (September 19, 2001)

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