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510(k) K181025

I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System by Neuro Kinetics, Inc. — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2018
Date Received
April 18, 2018
Clearance Type
Special
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

Other clearances by Neuro Kinetics, Inc.

  • K171884 — I-Portal Portable Assessment System - Nystagmograph (I-PAS) (November 22, 2017)
  • K143607 — I-Portal NOTC, VNG and VOG (July 8, 2015)
  • K083603 — I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMO (August 6, 2009)

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  • K181771 — RightEye Vision System (September 28, 2018)
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