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510(k) K083603

I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL by Neuro Kinetics — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2009
Date Received
December 5, 2008
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

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  • K143607 — I-Portal NOTC, VNG and VOG (July 8, 2015)

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