Identity
- Trade Name
- eego FDA UDI
- Generic Name
- Electroencephalographic monitoring system FDA UDI
- Device Name
- eeg recording and review FDA UDI
- Model / Reference
- ES-220 FDA UDI
- Description
- eeg recording and review FDA UDI
Identifiers
- Primary DI / UDI-DI
- B195ES220 FDA UDI
- 510(k) Number
- K051825 FDA UDI
- FDA Product Code
- GWQ FDA UDI
- GMDN Term
- Electroencephalographic monitoring system 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
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: Electroencephalographic monitoring system
eego by eemagine Medical Imaging Solutions GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electroencephalographic monitoring system.
- Pegasus Software License 256ch — NEURALYNX, INC. · Class II
- Pegasus Software License 224ch — NEURALYNX, INC. · Class II
- Enobio Dx — NEUROELECTRICS BARCELONA SL · Class II
- Enobio Dx — NEUROELECTRICS BARCELONA SL · Class II
- Pegasus Software License 416ch — NEURALYNX, INC. · Class II
- ATLAS NK HEADBOX — NEURALYNX, INC. · Class II
- NetCom Client — NEURALYNX, INC. · Class II
- REMI — Epitel, Inc. · Class II
Cleared under the same submission
K051825 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- eemagine Medical Imaging Solutions GmbH
Sources (1)
- FDA UDI f1a795c0-1d97-40d6-a92b-11f6c74332fa 35 fields · synced Jun 8, 2026