FDA 510(k)

Sontro® OTC Hearing Aids (AI)

Número K: K231550 · 2023-10-26

Data da decisão2023-10-26

Código do produtoQUH

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sontro® OTC Hearing Aids (AI) is the device name listed in this FDA 510(k) record. The listed applicant is Soundwave Hearing, LLC. It received FDA 510(k) clearance on 2023-10-26 under 510(k) number K231550. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sontro® OTC Hearing Aids (AI)?

Sontro® OTC Hearing Aids (AI) is a medical device that received FDA 510(k) clearance on 2023-10-26. The listed applicant is Soundwave Hearing, LLC. The 510(k) number is K231550.

When did Sontro® OTC Hearing Aids (AI) receive FDA 510(k) clearance?

Sontro® OTC Hearing Aids (AI) received FDA 510(k) clearance on 2023-10-26, under 510(k) number K231550.

Who is the listed applicant for Sontro® OTC Hearing Aids (AI)?

The FDA 510(k) record lists Soundwave Hearing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sontro® OTC Hearing Aids (AI)?

The FDA product code for Sontro® OTC Hearing Aids (AI) is QUH.

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