Identity
- Trade Name
- Component Neuromonitoring System FDA UDI
- Generic Name
- Electroencephalographic signal amplifier FDA UDI
- Device Name
- International (non-U.S.) model; optional 16 input EEG amplifier for direct recording of EEG and other physiological signals from the patient. FDA UDI
- Model / Reference
- CNS-EEG-220 FDA UDI
- Description
- International (non-U.S.) model; optional 16 input EEG amplifier for direct recording of EEG and other physiological signals from the patient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B485CNSEEG2201 FDA UDI
- 510(k) Number
- K080217 FDA UDI
- FDA Product Code
- GWQ FDA UDIORT FDA UDIMHX FDA UDIOMA FDA UDIOLT FDA UDIMUD FDA UDI
- GMDN Term
- Electroencephalographic signal amplifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI870.1025 FDA UDI870.2700 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: Electroencephalographic signal amplifier
Component Neuromonitoring System by Moberg Research, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electroencephalographic signal amplifier.
- XactTrode Patient Cable — Blackrock Microsystems · Class II
- eego amplifier — eemagine Medical Imaging Solutions GmbH · Class II
- XactTrode Patient Cable — Blackrock Microsystems · Class II
- XactTrode Patient Cable — Blackrock Microsystems · Class II
- ATLAS MICROMED JB INTERFACE — NEURALYNX, INC. · Class II
- XactTrode Patient Cable — Blackrock Microsystems · Class II
- ATLAS-HS-36-CHET-A9 — NEURALYNX, INC. · Class II
- Global Reference Module 1 — NEURALYNX, INC. · Class II
Cleared under the same submission
K080217 also covers:
- Component Monitoring System — Moberg Research, Inc.
- Component Monitoring System — Moberg Research, Inc.
- Component Monitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
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
- Moberg Research, Inc.
Sources (1)
- FDA UDI 83031b21-7368-4305-8013-10fe53ebe560 34 fields · synced May 30, 2026