FDA 510(k)

Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)

Номер K: K223694 · 2023-06-30

ЗаявительDuearity AB

Дата решения2023-06-30

Код продуктаKLW

Консультативный комитетEN

РешениеSubstantially Equivalent

Описание устройства

Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) is the device name listed in this FDA 510(k) record. The listed applicant is Duearity AB. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K223694. 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 Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)?

Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Duearity AB. The 510(k) number is K223694.

When did Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) receive FDA 510(k) clearance?

Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) received FDA 510(k) clearance on 2023-06-30, under 510(k) number K223694.

Who is the listed applicant for Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)?

The FDA 510(k) record lists Duearity AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)?

The FDA product code for Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) 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 K221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH K201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc.

Официальный источник

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