Class Class II

Tuned Self-Fitting Mobile App (K251208)

K251208 2025-09-26 Traditional
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Description

Tuned Self-Fitting Mobile App by Tuned , Ltd., an FDA 510(k) cleared ear, nose, throat device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251208
Clearance Date2025-09-26
Clearance TypeTraditional
Product CodeSCR
Regulation Number874.3335

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