NeuroOmega System NOM-000000-00

GUDID 07290014954007

ALPHA OMEGA ENGINEERING CO. LTD.

Electromyograph
Primary Device ID07290014954007
NIH Device Record Keybb82ff31-b47b-4c54-a047-259d64dad05c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroOmega System
Version Model NumberNeuro Omega System
Catalog NumberNOM-000000-00
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8779196288
Emailinfo@alphaomega-eng.com
Phone8779196288
Emailinfo@alphaomega-eng.com
Phone8779196288
Emailinfo@alphaomega-eng.com
Phone8779196288
Emailinfo@alphaomega-eng.com
Phone8779196288
Emailinfo@alphaomega-eng.com
Phone8779196288
Emailinfo@alphaomega-eng.com
Phone8779196288
Emailinfo@alphaomega-eng.com
Phone8779196288
Emailinfo@alphaomega-eng.com
Phone8779196288
Emailinfo@alphaomega-eng.com
Phone8779196288
Emailinfo@alphaomega-eng.com
Phone8779196288
Emailinfo@alphaomega-eng.com
Phone8779196288
Emailinfo@alphaomega-eng.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290014954007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IKNElectromyograph, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-22
Device Publish Date2016-09-24

Devices Manufactured by ALPHA OMEGA ENGINEERING CO. LTD.

07290114064057 - Remote Control2024-01-12
07290114064064 - Remote Control2024-01-12
07290114064071 - HaGuide Software2024-01-09
07290114064149 - Bengun W/O Screws2024-01-09
07290114064156 - Bengun Adapter2024-01-09
07290014954083 - NeuroSmart Main Unit2024-01-08
07290016450019 - NeuroSmart MER Headstage2024-01-08
07290114060790 - NeuroSmart NeuroForits Drive Headstage2024-01-08

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