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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
Predetermined Change
Control Plan Authorized		 No
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