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

Substantially Equivalent

Tuned , Ltd.

FDA 510(k) clearance K251208 for Tuned Self-Fitting Mobile App, Substantially Equivalent on 2025-09-26. Applicant: Tuned , Ltd.. Device class: 2.

Clearance details

Applicant: Tuned , Ltd.
Product code: Code SCR
Device class: Class 2
Regulation: 21 CFR 874.3335
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

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.