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510(k) K163270

ISEN-Goggles with Data Viewer by Isent Tech & Trading Company, Ltd. — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2017
Date Received
November 21, 2016
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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