510(k) K243709

Device
NeuroEars-Anna™
Applicant
Neuroears, Inc.
510(k) number
K243709
Product code
GWN
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-25
Date received
2024-12-02
Regulation
882.1460
Classification name
Nystagmograph
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Suh Kyoowon
Address
7, Huseok-Ro 462beon-Gil Chuncheon-Si Gangwon-Do KR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K163558Synapsys Ulmer Video NystagmographSynapsys SA2017-03-23
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