Identity
- Trade Name
- Component Neuromonitoring System FDA UDI
- Generic Name
- Electroencephalographic monitoring system FDA UDI
- Device Name
- Research model; a portable, computer-based system that can continuously record, display, store and analyze physiological data from multiple monitoring sources in real time. FDA UDI
- Model / Reference
- CNS-310 FDA UDI
- Description
- Research model; a portable, computer-based system that can continuously record, display, store and analyze physiological data from multiple monitoring sources in real time. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B485CNS3101 FDA UDI
- 510(k) Number
- K080217 FDA UDI
- FDA Product Code
- OLT FDA UDIMUD FDA UDIOMA FDA UDIMHX FDA UDIORT FDA UDIGWQ FDA UDI
- GMDN Term
- Electroencephalographic monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI870.2700 FDA UDI870.1025 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 monitoring system
Component Neuromonitoring System by Moberg Research, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Moberg Research, Inc.
Sources (1)
- FDA UDI 4010f53a-894b-4f57-ae5c-81eb48f96261 34 fields · synced May 30, 2026