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510(k) K182214

DizzyDoctor System 1.0.0 by Dizzydoctor Systems, LLC — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2018
Date Received
August 15, 2018
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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