FDA 510(k)

Bruxor

Номер K: K172452 · 2018-01-11

Дата решения2018-01-11

Код продуктаOBR

РешениеSubstantially Equivalent

Описание устройства

Bruxor is the device name listed in this FDA 510(k) record. The listed applicant is Sleep Specialties, LLC. It received FDA 510(k) clearance on 2018-01-11 under 510(k) number K172452. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Bruxor?

Bruxor is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Sleep Specialties, LLC. The 510(k) number is K172452.

When did Bruxor receive FDA 510(k) clearance?

Bruxor received FDA 510(k) clearance on 2018-01-11, under 510(k) number K172452.

Who is the listed applicant for Bruxor?

The FDA 510(k) record lists Sleep Specialties, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bruxor?

The FDA product code for Bruxor is OBR. This falls under the Orthopedic category.

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: OBR)

K262559Mouth GuardChangSha ChuangDuoLe E-Commerce Co., Ltd.K260790G-Series Grind GuardASESSO HEALTH, Inc.K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media Limited K253641Owl Night GuardOwl Dental Lab, Inc.K252004enCore Night GuardEncore Guards K251778Remi Custom Night GuardRemi

Официальный источник

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