NeuroEars-Anna— 510(k) K243709

Substantially Equivalent

Neuroears, Inc.

FDA 510(k) clearance K243709 for NeuroEars-Anna, Substantially Equivalent on 2025-08-25. Applicant: Neuroears, Inc..

Clearance details

Applicant: Neuroears, Inc.
Product code: Code GWN
Advisory panel: Neurology
Date received: 2024-12-02
Decision date: 2025-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gangwon-Do, KR

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