510(k) K203082
K203082 is an FDA 510(k) premarket notification submitted by Vestibular First for the device "Insight Infrared Video Goggles". The FDA issued a decision of Substantially Equivalent on November 12, 2020. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2020
- Date Received
- October 13, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Nystagmograph
- Device Class
- Class II
- Regulation Number
- 882.1460
- Review Panel
- NE
- Submission Type