回復 Back 3SE
K 號：K162828 · 2017-09-18
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器材摘要
Winback Back 3SE is the device name listed in this FDA 510(k) record. The listed applicant is Winback USA Corp. It received FDA 510(k) clearance on 2017-09-18 under 510(k) number K162828. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Winback Back 3SE?
Winback Back 3SE is a medical device that received FDA 510(k) clearance on 2017-09-18. The listed applicant is Winback USA Corp. The 510(k) number is K162828.
When did Winback Back 3SE receive FDA 510(k) clearance?
Winback Back 3SE received FDA 510(k) clearance on 2017-09-18, under 510(k) number K162828.
Who is the listed applicant for Winback Back 3SE?
The FDA 510(k) record lists Winback USA Corp as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Winback Back 3SE?
The FDA product code for Winback Back 3SE is PBX.
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：PBX）
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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