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510(k) K171884

I-Portal Portable Assessment System - Nystagmograph (I-PAS) by Neuro Kinetics, Inc. — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2017
Date Received
June 23, 2017
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.

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