Identity
- Trade Name
- Neuro Omega EMG HeadBox Kit FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Model / Reference
- Neuro Omega EMG HeadBox Kit FDA UDI
Identifiers
- Catalog Number
- 750-020013-00 FDA UDI
- Primary DI / UDI-DI
- 27290114060817 FDA UDI
- 510(k) Number
- K171581 FDA UDI
- FDA Product Code
- GWF FDA UDIIKN FDA UDI
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1870 FDA UDI890.1375 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
No
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
Category: Electromyograph
Neuro Omega EMG HeadBox Kit by Alpha Omega Engineering Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171581 also covers:
- Autoclavable Drive — Alpha Omega Engineering Corp.
- Autoclavable Drive — Alpha Omega Engineering Corp.
- Neuro Omega — Alpha Omega Engineering Corp.
- Neuro Omega — Alpha Omega Engineering Corp.
- Neuro Omega Autoclavable Drive Headstage — Alpha Omega Engineering Corp.
- Neuro Omega Autoclavable Drive Headstage KIT — Alpha Omega Engineering Corp.
- Neuro Omega Autoclavable Drive Headstage KIT (Autoclavable) — Alpha Omega Engineering Corp.
- Neuro Omega Drive Headstage — Alpha Omega Engineering Corp.
- Neuro Omega Drive Headstage Kit — Alpha Omega Engineering Corp.
- Neuro Omega Drive Headstage Kit — Alpha Omega Engineering Corp.
- Neuro Omega ECOG HeadBox Kit — Alpha Omega Engineering Corp.
- Neuro Omega ECOG HeadBox Kit — 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 ab30e79a-3347-4c58-b871-4a8c581f5915 34 fields · synced May 30, 2026