Neuro Omega System, NeuroSmart System

Electrode, Depth

Alpha Omega Engineering Ltd.

The following data is part of a premarket notification filed by Alpha Omega Engineering Ltd. with the FDA for Neuro Omega System, Neurosmart System.

Pre-market Notification Details

Device IDK220553
510k NumberK220553
Device Name:Neuro Omega System, NeuroSmart System
ClassificationElectrode, Depth
Applicant Alpha Omega Engineering Ltd. Hamerkava St.6, Tsiporit Industrial Zone Nof HaGalil (Nazareth Illit),  IL 1789062
ContactEfrat Shamgar
CorrespondentEfrat Shamgar
Alpha Omega Engineering Ltd. Hamerkava St.6, Tsiporit Industrial Zone Nof HaGalil (Nazareth Illit),  IL 1789062
Product CodeGZL  
Subsequent Product CodeGWF
Subsequent Product CodeGWQ
Subsequent Product CodeGYC
Subsequent Product CodeIKN
CFR Regulation Number882.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-28
Decision Date2022-09-16

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