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510(k) K203082

Insight Infrared Video Goggles by Vestibular First — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2020
Date Received
October 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Nystagmograph
Device Class
Class II
Regulation Number
882.1460
Review Panel
NE
Submission Type

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