Identity
- Trade Name
- COGNISION EEG/EP System FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- COGNISION EEG/EP System. Includes headset, headset control unit, earphones, cables, and system case. FDA UDI
- Model / Reference
- 3000 FDA UDI
- Description
- COGNISION EEG/EP System. Includes headset, headset control unit, earphones, cables, and system case. FDA UDI
Identifiers
- Catalog Number
- H1000 FDA UDI
- Primary DI / UDI-DI
- B706H10000 FDA UDI
- 510(k) Number
- K141316 FDA UDI
- FDA Product Code
- OMC FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electroencephalograph
COGNISION EEG/EP System by Neuronetrix Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electroencephalograph.
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- Compumedics Neuvo — COMPUMEDICS LIMITED · Class II
- Zeto ONE Head Unit - Small — ZETO INC · Class II
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
- Neuronetrix Solutions
Sources (1)
- FDA UDI cc1f5dea-ca15-433d-8396-6b497755c983 36 fields · synced May 30, 2026