Identity
- Trade Name
- NeuroOmega System FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Model / Reference
- Neuro Omega System FDA UDI
Identifiers
- Catalog Number
- NOM-000000-00 FDA UDI
- Primary DI / UDI-DI
- 07290014954007 FDA UDI
- 510(k) Number
- K123796 FDA UDI
- FDA Product Code
- IKN FDA UDIGWQ FDA UDIGWF FDA UDIGZL FDA UDI
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1375 FDA UDI882.1400 FDA UDI882.1870 FDA UDI882.1330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Neurological stereotactic surgery systemElectromyograph
NeuroOmega System by Alpha Omega Engineering Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electromyograph.
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- Natus — Xltek · Class II
Cleared under the same submission
K123796 also covers:
- Neuro Omega HS — Alpha Omega Engineering Corp.
- Neuro Omega HS — Alpha Omega Engineering Corp.
- Neuro Omega Input Cable — Alpha Omega Engineering Corp.
- Neuro Omega Input Cable — Alpha Omega Engineering Corp.
- Neuro Omega Input Cable — Alpha Omega Engineering Corp.
- Neuro Omega Input Cable — Alpha Omega Engineering Corp.
- Neuro Omega Input Cable — Alpha Omega Engineering Corp.
- Neuro Omega Input Cable — Alpha Omega Engineering Corp.
- Neuro Omega Input Cable — Alpha Omega Engineering Corp.
- Neuro Omega Input Cable — Alpha Omega Engineering Corp.
- Neuro Omega Input Cable — Alpha Omega Engineering Corp.
- NeuroOmega Autoclavable — Alpha Omega Engineering Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alpha Omega Engineering Corp.
Sources (1)
- FDA UDI bb82ff31-b47b-4c54-a047-259d64dad05c 35 fields · synced May 30, 2026