Intact® Gen2 系統
K 號：K152596 · 2016-02-15
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器材摘要
Intact® Gen2 System is the device name listed in this FDA 510(k) record. The listed applicant is Intact Medical Corporation. It received FDA 510(k) clearance on 2016-02-15 under 510(k) number K152596. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Intact® Gen2 System?
Intact® Gen2 System is a medical device that received FDA 510(k) clearance on 2016-02-15. The listed applicant is Intact Medical Corporation. The 510(k) number is K152596.
When did Intact® Gen2 System receive FDA 510(k) clearance?
Intact® Gen2 System received FDA 510(k) clearance on 2016-02-15, under 510(k) number K152596.
Who is the listed applicant for Intact® Gen2 System?
The FDA 510(k) record lists Intact Medical Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Intact® Gen2 System?
The FDA product code for Intact® Gen2 System is KNW.
相關臨床試驗
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相關器械（代碼：KNW）
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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