EchoGo 核心
K号: K191171 · 2019-11-13
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器械摘要
EchoGo Core is the device name listed in this FDA 510(k) record. The listed applicant is Ultromics, Ltd.. It received FDA 510(k) clearance on 2019-11-13 under 510(k) number K191171. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EchoGo Core?
EchoGo Core is a medical device that received FDA 510(k) clearance on 2019-11-13. The listed applicant is Ultromics, Ltd.. The 510(k) number is K191171.
When did EchoGo Core receive FDA 510(k) clearance?
EchoGo Core received FDA 510(k) clearance on 2019-11-13, under 510(k) number K191171.
Who is the listed applicant for EchoGo Core?
The FDA 510(k) record lists Ultromics, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EchoGo Core?
The FDA product code for EchoGo Core is QIH.
相关临床试验
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列明Ultromics, Ltd.为申报人的其他记录
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相关器械（代码：QIH）
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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