SmoothSkin BARE+
K 號：K192010 · 2019-09-24
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器材摘要
SmoothSkin BARE+ is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2019-09-24 under 510(k) number K192010. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SmoothSkin BARE+?
SmoothSkin BARE+ is a medical device that received FDA 510(k) clearance on 2019-09-24. The listed applicant is Cyden Limited. The 510(k) number is K192010.
When did SmoothSkin BARE+ receive FDA 510(k) clearance?
SmoothSkin BARE+ received FDA 510(k) clearance on 2019-09-24, under 510(k) number K192010.
Who is the listed applicant for SmoothSkin BARE+?
FDA 510(k) 記錄將 Cyden Limited 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for SmoothSkin BARE+?
The FDA product code for SmoothSkin BARE+ is OHT.
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。
其他以 Cyden Limited 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：OHT）
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。
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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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