真護自訂舌頭及下巴定位器
K 號：K153270 · 2016-03-08
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器材摘要
TruGuard Custom Tongue and Jaw Positioner is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corp.. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K153270. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TruGuard Custom Tongue and Jaw Positioner?
TruGuard Custom Tongue and Jaw Positioner is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Bionix Development Corp.. The 510(k) number is K153270.
When did TruGuard Custom Tongue and Jaw Positioner receive FDA 510(k) clearance?
TruGuard Custom Tongue and Jaw Positioner received FDA 510(k) clearance on 2016-03-08, under 510(k) number K153270.
Who is the listed applicant for TruGuard Custom Tongue and Jaw Positioner?
The FDA 510(k) record lists Bionix Development Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TruGuard Custom Tongue and Jaw Positioner?
The FDA product code for TruGuard Custom Tongue and Jaw Positioner is IYE.
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：IYE）
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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