Nuance Audio Hearing Aid Software
K-Number: K243150 · 2025-01-31
ApplicantLuxottica Group S.P.A.
Decision Date2025-01-31
Product CodeSCR
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Nuance Audio Hearing Aid Software is a medical device manufactured by Luxottica Group S.P.A.. It received FDA 510(k) clearance on 2025-01-31 under approval number K243150. The device is classified under product code SCR. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Nuance Audio Hearing Aid Software?
Nuance Audio Hearing Aid Software is a medical device that received FDA 510(k) clearance on 2025-01-31. It is manufactured by Luxottica Group S.P.A.. The 510(k) number is K243150.
When was Nuance Audio Hearing Aid Software approved by the FDA?
Nuance Audio Hearing Aid Software received FDA 510(k) clearance on 2025-01-31, under approval number K243150.
What company makes Nuance Audio Hearing Aid Software?
Nuance Audio Hearing Aid Software is manufactured by Luxottica Group S.P.A..
What is the FDA product code for Nuance Audio Hearing Aid Software?
The FDA product code for Nuance Audio Hearing Aid Software is SCR.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.