FDA 510(k)

TinniLogic Mobile Tinnitus Management Device

Номер K: K163094 · 2017-05-17

ЗаявительJiangsu Betterlife Medical Co., Ltd.

Дата решения2017-05-17

Код продуктаKLW

Консультативный комитетEN

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: KLW)

K260413Levo Gen 2 Tinnitus Therapy SystemLevo Medical Corporation K260614Tinnitus TherapySivantos GmbH K233435Peace N Quiet (0.7.0)Pnq Health K223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity AB K221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH

Официальный источник

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