Yxoss CBR®
K号: K192747 · 2020-06-17
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申请人Reoss GmbH
决定日期2020-06-17
产品代码JEY
咨询委员会DE
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器械摘要
Yxoss CBR® is the device name listed in this FDA 510(k) record. The listed applicant is Reoss GmbH. It received FDA 510(k) clearance on 2020-06-17 under 510(k) number K192747. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Yxoss CBR®?
Yxoss CBR® is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Reoss GmbH. The 510(k) number is K192747.
When did Yxoss CBR® receive FDA 510(k) clearance?
Yxoss CBR® received FDA 510(k) clearance on 2020-06-17, under 510(k) number K192747.
Who is the listed applicant for Yxoss CBR®?
The FDA 510(k) record lists Reoss GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Yxoss CBR®?
The FDA product code for Yxoss CBR® is JEY.
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：JEY）
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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