Home / 510(k) Clearances / K030737

510(k) K030737

OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 by Ctf Systems (2001), Inc. — Product Code OLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2003
Date Received
March 10, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization

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