Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615126

FEI Number

3001610756

Entity Name

ALPHA OMEGA ENGINEERING LTD.

City/State/Country

Nof HaGalil Northern, IL

Establishment Address

Hamerkava St. 6, Tsiporit Industrial Zone, Nof HaGalil Northern 1789062, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ALPHA OMEGA ENGINEERING LTD. (Owner Number: 9039414)

Owner / Operator Contact Address

Hamerkava st.6, Tsiporit Industrial Zone, Nof HaGalil (Nazareth Illit), IL-Z 1789062, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterile Cannula Sterile NeuroProbe Sterile Electrode Cable MicroGuide Neuro Omega NeuroSmart NeuroSmart system Neuro Omega system NeuroFortis Neuro Omega Drive Headstage Neuro Omega MER Headstage Neuro Omega Drive Headstage Neuro Omega Autoclavable Drive Neuro Omega Autoclavable Drive Headstage Neuro Omega with Neuro Omega drive + 2 basic stimulation Slots Neuro Omega with Neuro Omega drive + 1 basic stimulation Slot Neuro Omega with NeuroFortis drive + 1 basic stimulation Slot Neuro Omega EMG HeadBox Kit Neuro Omega with NeuroFortis drive + 2 basic stimulation Slots Neuro Omega ECOG HeadBox Kit Sterile LeadConfirm A Cable Sterile LeadConfirm B Cable Sterile LeadConfirm M Adaptor Sterile LeadConfirm A Adaptor Sterile LeadConfirm M Cable NeuroNav NeuroSmart NeuroFortis NeuroSmart Drive Headstage NeuroNav NeuroNav Drive Headstage NeuroSmart MER Headstage NeuroNav MER Headstage NeuroNav with Autoclavable Drive Headstage NeuroSmart Autoclavable Drive Headstage Kit NeuroNav Drive Headstage Kit NeuroNav with NeuroNav Drive NeuroSmart MER Headstage Kit NeuroSmart with AutoClavable Drive Headstage NeuroFortis NeuroSmart Drive Headstage Kit NeuroNav with MER Headstage NeuroNav MER Headstage Kit NeuroNav with NeuroFortis Drive NeuroSmart Autoclavable Drive Headstage NeuroSmart with NeuroFortis Drive NeuroProbe aCare SENS Cannula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2013-03-07
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2008-03-19
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2025-12-18
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2025-12-18
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2025-12-18
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2025-12-18
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2025-12-18
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-12-06
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2022-12-06
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2022-12-06
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2022-12-06
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2022-12-06
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2018-03-13
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2018-03-13
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2018-03-13
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2018-03-13
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2018-03-13
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2020-01-06
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2008-03-19
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2018-03-13
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2008-03-19
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2021-06-01
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-11-15

Official Correspondent

No official correspondent registered.

US Agent Details

Mulham Jabaly Email: m.jabaly@alphaomega-eng.com Phone: (972) 6563327

Related Public Records

Same Entity

ALPHA OMEGA ENGINEERING LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

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3008534770	SYMMETRY MEDICAL POLYVAC SAS	WAMBRECHIES Nord, FR
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615126. Last updated year: 2026. Please use registration number 9615126 when referencing this establishment in official correspondence.