Class Class II

Nuance Audio Hearing Aid Software (K243150)

K243150 2025-01-31 Traditional
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Description

Nuance Audio Hearing Aid Software by Luxottica Group S.P.A., an FDA 510(k) cleared ear, nose, throat device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK243150
Clearance Date2025-01-31
Clearance TypeTraditional
Product CodeSCR
Regulation Number874.3335

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