FDA 510(k)

Sound Options Tinnitus Treatment

Número K: K161562 · 2016-09-28

RequerenteSound Options Tinnitus Treatments, Inc.

Data da decisão2016-09-28

Código do produtoKLW

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sound Options Tinnitus Treatment is the device name listed in this FDA 510(k) record. The listed applicant is Sound Options Tinnitus Treatments, Inc.. It received FDA 510(k) clearance on 2016-09-28 under 510(k) number K161562. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sound Options Tinnitus Treatment?

Sound Options Tinnitus Treatment is a medical device that received FDA 510(k) clearance on 2016-09-28. The listed applicant is Sound Options Tinnitus Treatments, Inc.. The 510(k) number is K161562.

When did Sound Options Tinnitus Treatment receive FDA 510(k) clearance?

Sound Options Tinnitus Treatment received FDA 510(k) clearance on 2016-09-28, under 510(k) number K161562.

Who is the listed applicant for Sound Options Tinnitus Treatment?

The FDA 510(k) record lists Sound Options Tinnitus Treatments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sound Options Tinnitus Treatment?

The FDA product code for Sound Options Tinnitus Treatment is KLW.

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