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510(k) K192186

I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph by Neurolign USA, LLC — Product Code GWN

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

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