奧斯卡2
K 號：K151520 · 2016-02-19
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器材摘要
Oscar 2 is the device name listed in this FDA 510(k) record. The listed applicant is Suntech Medical, Inc.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K151520. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Oscar 2?
Oscar 2 is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Suntech Medical, Inc.. The 510(k) number is K151520.
When did Oscar 2 receive FDA 510(k) clearance?
Oscar 2 received FDA 510(k) clearance on 2016-02-19, under 510(k) number K151520.
Who is the listed applicant for Oscar 2?
The FDA 510(k) record lists Suntech Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Oscar 2?
The FDA product code for Oscar 2 is DXN.
相關臨床試驗
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相關器械（代碼：DXN）
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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