雙重設備名稱醫療設備規範文本 DUO
K 號：K161565 · 2016-09-01
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決定日期2016-09-01
產品代碼ONF
諮詢委員會SU
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決定相當於
器材摘要
DUO is the device name listed in this FDA 510(k) record. The listed applicant is Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K161565. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DUO?
DUO is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd. The 510(k) number is K161565.
When did DUO receive FDA 510(k) clearance?
DUO received FDA 510(k) clearance on 2016-09-01, under 510(k) number K161565.
Who is the listed applicant for DUO?
The FDA 510(k) record lists Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DUO?
The FDA product code for DUO is ONF.
相關 PubMed 文獻
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相關器械（代碼：ONF）
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
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