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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 K250601
Device Name Neuro Omega System; NeuroSmart System
Applicant
Alpha Omega Engineering , Ltd.
Hamerkava St. 6 Tsiporit Industrial Zone
P.O. Box 810
Nof Hagalil (Nazareth Illit),  IL 1789062
Applicant Contact Efrat Shamgar
Correspondent
Alpha Omega Engineering , Ltd.
Hamerkava St. 6 Tsiporit Industrial Zone
P.O. Box 810
Nof Hagalil (Nazareth Illit),  IL 1789062
Correspondent Contact Efrat Shamgar
Regulation Number882.1330
Classification Product Code
GZL  
Subsequent Product Codes
GWF   GWQ   GYC   IKN  
Date Received02/28/2025
Decision Date 03/30/2025
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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