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510(k) K152727

ISEN-Goggles by Isen Tech & Trading Company, Ltd. — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2016
Date Received
September 22, 2015
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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