Goyo 口罩
K 號：K232238 · 2024-04-17
廣告
器材摘要
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.
常見問題
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.
相關臨床試驗
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
相關器械（代碼：OBR）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
廣告