Goyo Mouthpiece S
K-Number: K232238 · 2024-04-17
Device Summary
Goyo Mouthpiece S is a medical device manufactured by Dimedikorea. It received FDA 510(k) clearance on 2024-04-17 under approval 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.
Frequently Asked Questions
What is the Goyo Mouthpiece S?
Goyo Mouthpiece S is a medical device that received FDA 510(k) clearance on 2024-04-17. It is manufactured by Dimedikorea. The 510(k) number is K232238.
When was Goyo Mouthpiece S approved by the FDA?
Goyo Mouthpiece S received FDA 510(k) clearance on 2024-04-17, under approval number K232238.
What company makes Goyo Mouthpiece S?
Goyo Mouthpiece S is manufactured by Dimedikorea.
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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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.