Identity
- Trade Name
- Visual System HD FDA UDI
- Generic Name
- Visual stimulator FDA UDI
- Device Name
- The VisualSystem HD 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 (Visual System HD) FDA UDI
- Model / Reference
- VHD-1.1 FDA UDI
- Description
- The VisualSystem HD 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 (Visual System HD) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07090042052085 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
Yes
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 HD by Nordicneurolab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Visual stimulator.
- SightSaverMini — Anschel Technology, Inc. · Class II
- USB FLASH ADAPTER CABLE L=3m — EB NEURO SPA · Class II
- USB FLASH ADAPTER CABLE L=5m — EB NEURO SPA · Class II
- Visual Stimulation Box — Intelligent Hearing Systems Corp. · Class II
- Flash Led Stimulator — EB NEURO SPA · Class II
- Coil Mounted Display — Nordicneurolab · Class II
- LCD Power Supply — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nordicneurolab
Sources (1)
- FDA UDI b0ec34aa-6b81-4167-aacc-ffd91ac1ef23 34 fields · synced May 29, 2026