FDA 510(k)

TruGuard Custom Tongue and Jaw Positioner

Номер K: K153270 · 2016-03-08

Дата решения2016-03-08

Код продуктаIYE

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

TruGuard Custom Tongue and Jaw Positioner is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corp.. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K153270. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the TruGuard Custom Tongue and Jaw Positioner?

TruGuard Custom Tongue and Jaw Positioner is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Bionix Development Corp.. The 510(k) number is K153270.

When did TruGuard Custom Tongue and Jaw Positioner receive FDA 510(k) clearance?

TruGuard Custom Tongue and Jaw Positioner received FDA 510(k) clearance on 2016-03-08, under 510(k) number K153270.

Who is the listed applicant for TruGuard Custom Tongue and Jaw Positioner?

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

What is the FDA product code for TruGuard Custom Tongue and Jaw Positioner?

The FDA product code for TruGuard Custom Tongue and Jaw Positioner is IYE.

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: IYE)

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Официальный источник

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