Identity
- Trade Name
- Pegasus Software License 256ch FDA UDI
- Generic Name
- Electroencephalographic monitoring system FDA UDI
- Device Name
- The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System. FDA UDI
- Model / Reference
- 256 Channel FDA UDI
- Description
- The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System. FDA UDI
Identifiers
- Catalog Number
- 36-0301-0037 FDA UDI
- Primary DI / UDI-DI
- 00850011306819 FDA UDI
- 510(k) Number
- K110967 FDA UDI
- FDA Product Code
- OMC 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electroencephalographic monitoring system
Pegasus Software License 256ch by Neuralynx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K110967 also covers:
- ATLAS ANALOG ISOLATOR — NEURALYNX, INC.
- ATLAS COMBO BOARD — NEURALYNX, INC.
- ATLAS Ground Drive — NEURALYNX, INC.
- ATLAS HC HEADBOX — NEURALYNX, INC.
- ATLAS HD HEADBOX — NEURALYNX, INC.
- ATLAS HEADBOX — NEURALYNX, INC.
- ATLAS Headbox Expansion Panel — NEURALYNX, INC.
- ATLAS NK HEADBOX — NEURALYNX, INC.
- ATLAS Neurophysiology System — NEURALYNX, INC.
- ATLAS Parallel TTL Cable — NEURALYNX, INC.
- ATLAS Power Isolator 110VAC — NEURALYNX, INC.
- ATLAS Power Isolator 220VAC — NEURALYNX, 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
- Neuralynx, Inc.
Sources (1)
- FDA UDI 6e843d61-e151-47ce-9cc6-ad7faea26fac 35 fields · synced May 30, 2026