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510(k) K181771

RightEye Vision System by Righteye, LLC — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2018
Date Received
July 3, 2018
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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