510(k) K192186
K192186 is an FDA 510(k) premarket notification submitted by Neurolign USA, LLC for the device "I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph". The FDA issued a decision of Substantially Equivalent on November 29, 2019. 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 29, 2019
- Date Received
- August 12, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nystagmograph
- Device Class
- Class II
- Regulation Number
- 882.1460
- Review Panel
- NE
- Submission Type