Immuno Concepts图像导航器
K号: K160265 · 2016-06-17
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决定日期2016-06-17
产品代码DHN
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器械摘要
Image Navigator by Immuno Concepts is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Concepts, N.A. , Ltd.. It received FDA 510(k) clearance on 2016-06-17 under 510(k) number K160265. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Image Navigator by Immuno Concepts?
Image Navigator by Immuno Concepts is a medical device that received FDA 510(k) clearance on 2016-06-17. The listed applicant is Immuno Concepts, N.A. , Ltd.. The 510(k) number is K160265.
When did Image Navigator by Immuno Concepts receive FDA 510(k) clearance?
Image Navigator by Immuno Concepts received FDA 510(k) clearance on 2016-06-17, under 510(k) number K160265.
Who is the listed applicant for Image Navigator by Immuno Concepts?
The FDA 510(k) record lists Immuno Concepts, N.A. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Image Navigator by Immuno Concepts?
The FDA product code for Image Navigator by Immuno Concepts is DHN.
相关临床试验
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列明Immuno Concepts, N.A. , Ltd.为申报人的其他记录
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：DHN）
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。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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