Neuro Omega EMG HeadBox Kit 750-020013-00

GUDID 27290114060817

ALPHA OMEGA ENGINEERING CO. LTD.

Electromyograph
Primary Device ID27290114060817
NIH Device Record Keyab30e79a-3347-4c58-b871-4a8c581f5915
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro Omega EMG HeadBox Kit
Version Model NumberNeuro Omega EMG HeadBox Kit
Catalog Number750-020013-00
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS127290114060817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWFStimulator, Electrical, Evoked Response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-12
Device Publish Date2020-05-04

On-Brand Devices [Neuro Omega EMG HeadBox Kit]

27290114060817Neuro Omega EMG HeadBox Kit
27290114063214Neuro Omega EMG HeadBox Kit

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