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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name source localization software for electroencephalograph or magnetoencephalograph
510(k) Number K030737
Device Name OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
Applicant
CTF SYSTEMS (2001), INC.
15-1750 MCLEAN AVE.
PORT COQUITLAM, B.C.,  CA V3C 1M9
Applicant Contact DARYL WISDAHL
Correspondent
CTF SYSTEMS (2001), INC.
15-1750 MCLEAN AVE.
PORT COQUITLAM, B.C.,  CA V3C 1M9
Correspondent Contact DARYL WISDAHL
Regulation Number882.1400
Classification Product Code
OLX  
Subsequent Product Code
OLY  
Date Received03/10/2003
Decision Date 10/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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