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510(k) K243709

NeuroEars-Anna™ by Neuroears, Inc. — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2025
Date Received
December 2, 2024
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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