FDA 510(k)

TinniLogic Mobile Tinnitus Management Device

Número K: K163094 · 2017-05-17

RequerenteJiangsu Betterlife Medical Co., Ltd.

Data da decisão2017-05-17

Código do produtoKLW

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

TinniLogic Mobile Tinnitus Management Device is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Betterlife Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-05-17 under 510(k) number K163094. 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 TinniLogic Mobile Tinnitus Management Device?

TinniLogic Mobile Tinnitus Management Device is a medical device that received FDA 510(k) clearance on 2017-05-17. The listed applicant is Jiangsu Betterlife Medical Co., Ltd.. The 510(k) number is K163094.

When did TinniLogic Mobile Tinnitus Management Device receive FDA 510(k) clearance?

TinniLogic Mobile Tinnitus Management Device received FDA 510(k) clearance on 2017-05-17, under 510(k) number K163094.

Who is the listed applicant for TinniLogic Mobile Tinnitus Management Device?

The FDA 510(k) record lists Jiangsu Betterlife Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TinniLogic Mobile Tinnitus Management Device?

The FDA product code for TinniLogic Mobile Tinnitus Management Device is KLW.

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