Brux 夜間護牙器
K 號：K181361 · 2019-04-11
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器材摘要
Brux Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is Brux Night Guard. It received FDA 510(k) clearance on 2019-04-11 under 510(k) number K181361. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
常見問題
What is the Brux Night Guard?
Brux Night Guard is a medical device that received FDA 510(k) clearance on 2019-04-11. The listed applicant is Brux Night Guard. The 510(k) number is K181361.
When did Brux Night Guard receive FDA 510(k) clearance?
Brux Night Guard received FDA 510(k) clearance on 2019-04-11, under 510(k) number K181361.
Who is the listed applicant for Brux Night Guard?
The FDA 510(k) record lists Brux Night Guard as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Brux Night Guard?
The FDA product code for Brux Night Guard is MQC.
相關臨床試驗
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相關器械（代碼：MQC）
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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