Intact® Gen2 系统
K号: K152596 · 2016-02-15
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决定日期2016-02-15
产品代码KNW
咨询委员会GU
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器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：KNW）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
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