EndoCure 模型 EUR078A
K号: K161147 · 2016-06-07
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决定日期2016-06-07
产品代码FBN
咨询委员会GU
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决定实质等同
器械摘要
EndoCure Model EUR078A is the device name listed in this FDA 510(k) record. The listed applicant is Endocure Technologies, Inc.. It received FDA 510(k) clearance on 2016-06-07 under 510(k) number K161147. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EndoCure Model EUR078A?
EndoCure Model EUR078A is a medical device that received FDA 510(k) clearance on 2016-06-07. The listed applicant is Endocure Technologies, Inc.. The 510(k) number is K161147.
When did EndoCure Model EUR078A receive FDA 510(k) clearance?
EndoCure Model EUR078A received FDA 510(k) clearance on 2016-06-07, under 510(k) number K161147.
Who is the listed applicant for EndoCure Model EUR078A?
The FDA 510(k) record lists Endocure Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EndoCure Model EUR078A?
The FDA product code for EndoCure Model EUR078A is FBN.
相关临床试验
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相关器械（代码：FBN）
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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