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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Depth
510(k) Number K123796
Device Name NEURO OMEGA SYSTEM
Applicant
Alpha Omega Engineering , Ltd.
P.O. Box 4414 (A109)
Caesarea,  IL 30889
Applicant Contact ILAN SHARON
Correspondent
Alpha Omega Engineering , Ltd.
P.O. Box 4414 (A109)
Caesarea,  IL 30889
Correspondent Contact ILAN SHARON
Regulation Number882.1330
Classification Product Code
GZL  
Subsequent Product Codes
GWF   GWQ   IKN  
Date Received12/10/2012
Decision Date 04/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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