Identity
- Trade Name
- Visual System Power Supply FDA UDI
- Generic Name
- Visual stimulator FDA UDI
- Device Name
- Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HD Shielded enclosure containing the Power Supply Unit for the Visual System HD which is located in the MR environment. VPS is part of NordicNeuroLab’s VisualSystem HD. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays. FDA UDI
- Model / Reference
- VPS-1.1 FDA UDI
- Description
- Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HD Shielded enclosure containing the Power Supply Unit for the Visual System HD which is located in the MR environment. VPS is part of NordicNeuroLab’s VisualSystem HD. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07090042052092 FDA UDI
- 510(k) Number
- K191032 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Visual stimulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 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
MR Conditional FDA UDI
Category: Visual stimulator
Visual System Power Supply by Nordicneurolab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Visual stimulator.
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- Visual Stimulation Box — Intelligent Hearing Systems Corp. · Class II
- Flash Led Stimulator — EB NEURO SPA · Class II
- Visual System HD — Nordicneurolab · Class II
- Coil Mounted Display — Nordicneurolab · Class II
- LCD Power Supply — Nordicneurolab · Class II
Cleared under the same submission
K191032 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 |
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Manufacturer
- Manufacturer
- Nordicneurolab
Sources (1)
- FDA UDI 7f5c0151-0f8f-47a0-b472-4c802d307ddb 34 fields · synced Jun 8, 2026