FDA 510(k)

Goyo Mouthpiece S

Número K: K232238 · 2024-04-17

Data da decisão2024-04-17

Código do produtoOBR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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