Identity
- Trade Name
- NEBA Compact EEG System FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Neuropsychiatric interpretive electroencephalograph assessment aid. Uses a patient's electroencephalograph (eeg) to provide an interpretation of the patient's neuropsychiatric condition.It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis FDA UDI
- Model / Reference
- 7200101 FDA UDI
- Description
- Neuropsychiatric interpretive electroencephalograph assessment aid. Uses a patient's electroencephalograph (eeg) to provide an interpretation of the patient's neuropsychiatric condition.It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863414000314 FDA UDI
- 510(k) Number
- DEN110019 FDA UDI
- FDA Product Code
- NCG FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1440 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
Category: Electroencephalograph
NEBA Compact EEG System by Neba Health, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Neba Health, LLC
Sources (1)
- FDA UDI 2ab7115d-0596-45f6-87de-9100bc6a053c 34 fields · synced May 30, 2026