510(k) K251208— Tuned Self-Fitting Mobile App

Substantially Equivalent

Tuned , Ltd.

Clearance details

Applicant: Tuned , Ltd.
Product code: Code SCR
Advisory panel: Ear, Nose, Throat
Date received: 2025-04-18
Decision date: 2025-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gan Yoshiya, IL

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