NeuroOmega System NOM-000000-00

GUDID 07290014954007

ALPHA OMEGA ENGINEERING CO. LTD.

Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph

• Primary Device ID: 07290014954007
• NIH Device Record Key: bb82ff31-b47b-4c54-a047-259d64dad05c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroOmega System
• Version Model Number: Neuro Omega System
• Catalog Number: NOM-000000-00
• Company DUNS: 531856466
• Company Name: ALPHA OMEGA ENGINEERING CO. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8779196288
• Email: info@alphaomega-eng.com
• Phone: 8779196288
• Email: info@alphaomega-eng.com
• Phone: 8779196288
• Email: info@alphaomega-eng.com
• Phone: 8779196288
• Email: info@alphaomega-eng.com
• Phone: 8779196288
• Email: info@alphaomega-eng.com
• Phone: 8779196288
• Email: info@alphaomega-eng.com
• Phone: 8779196288
• Email: info@alphaomega-eng.com
• Phone: 8779196288
• Email: info@alphaomega-eng.com
• Phone: 8779196288
• Email: info@alphaomega-eng.com
• Phone: 8779196288
• Email: info@alphaomega-eng.com
• Phone: 8779196288
• Email: info@alphaomega-eng.com
• Phone: 8779196288
• Email: info@alphaomega-eng.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290014954007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123796

FDA Product Code

• IKN: Electromyograph, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-22
• Device Publish Date: 2016-09-24

Devices Manufactured by ALPHA OMEGA ENGINEERING CO. LTD.

• 07290114064057 - Remote Control: 2024-01-12
• 07290114064064 - Remote Control: 2024-01-12
• 07290114064071 - HaGuide Software: 2024-01-09
• 07290114064149 - Bengun W/O Screws: 2024-01-09
• 07290114064156 - Bengun Adapter: 2024-01-09
• 07290014954083 - NeuroSmart Main Unit: 2024-01-08
• 07290016450019 - NeuroSmart MER Headstage: 2024-01-08
• 07290114060790 - NeuroSmart NeuroForits Drive Headstage: 2024-01-08