緊握保護器
K 號：K181005 · 2020-01-15
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器材摘要
ClenchGuard is the device name listed in this FDA 510(k) record. The listed applicant is Boyd Research, Inc.. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K181005. 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 ClenchGuard?
ClenchGuard is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Boyd Research, Inc.. The 510(k) number is K181005.
When did ClenchGuard receive FDA 510(k) clearance?
ClenchGuard received FDA 510(k) clearance on 2020-01-15, under 510(k) number K181005.
Who is the listed applicant for ClenchGuard?
The FDA 510(k) record lists Boyd Research, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ClenchGuard?
The FDA product code for ClenchGuard is OBR. This falls under the Orthopedic category.
相關臨床試驗
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其他以 Boyd Research, Inc. 為申請人之記錄
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。
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