FDA 510(k)

Goyo Mouthpiece S

Номер K: K232238 · 2024-04-17

ЗаявительDimedikorea

Дата решения2024-04-17

Код продуктаOBR

РешениеSubstantially Equivalent

Описание устройства

Goyo Mouthpiece S is the device name listed in this FDA 510(k) record. The listed applicant is Dimedikorea. It received FDA 510(k) clearance on 2024-04-17 under 510(k) number K232238. 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 Goyo Mouthpiece S?

Goyo Mouthpiece S is a medical device that received FDA 510(k) clearance on 2024-04-17. The listed applicant is Dimedikorea. The 510(k) number is K232238.

When did Goyo Mouthpiece S receive FDA 510(k) clearance?

Goyo Mouthpiece S received FDA 510(k) clearance on 2024-04-17, under 510(k) number K232238.

Who is the listed applicant for Goyo Mouthpiece S?

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

What is the FDA product code for Goyo Mouthpiece S?

The FDA product code for Goyo Mouthpiece S 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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