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510(k) K143607

I-Portal NOTC, VNG and VOG by Neuro Kinetics, Inc. — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2015
Date Received
December 19, 2014
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

Other clearances by Neuro Kinetics, Inc.

  • K181025 — I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Por (July 24, 2018)
  • K171884 — I-Portal Portable Assessment System - Nystagmograph (I-PAS) (November 22, 2017)
  • K083603 — I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMO (August 6, 2009)

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