Identity
- Trade Name
- Vestibular First FDA UDI
- Generic Name
- Vision/eye movement analysis system FDA UDI
- Device Name
- The Insight Infrared Video Goggles are designed to be used by clinicians to visualize and record patient eye movements. The goggles will be placed on the patient’s head with the cameras in front of the patient’s eyes. The infrared cameras transmit video of the eye movements to a compatible computer screen for display. The computer uses an off-the-shelf video software Open Broadcaster Software (OBS) to allow viewing and recording of the cameras. FDA UDI
- Model / Reference
- Insight Infrared Video Goggles FDA UDI
- Description
- The Insight Infrared Video Goggles are designed to be used by clinicians to visualize and record patient eye movements. The goggles will be placed on the patient’s head with the cameras in front of the patient’s eyes. The infrared cameras transmit video of the eye movements to a compatible computer screen for display. The computer uses an off-the-shelf video software Open Broadcaster Software (OBS) to allow viewing and recording of the cameras. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860002280707 FDA UDI
- 510(k) Number
- K203082 FDA UDI
- FDA Product Code
- GWN FDA UDI
- GMDN Term
- Vision/eye movement analysis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1460 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vision/eye movement analysis system
Vestibular First by Vestibular First — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K203082 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
- Vestibular First
Sources (1)
- FDA UDI d833038b-1e92-4942-b21d-67cc61c7fc23 36 fields · synced Jun 6, 2026