Yarlap II
K号: K160773 · 2016-05-04
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决定日期2016-05-04
产品代码KPI
咨询委员会GU
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决定实质等同
器械摘要
Yarlap II is the device name listed in this FDA 510(k) record. The listed applicant is International Trade Group, Inc.. It received FDA 510(k) clearance on 2016-05-04 under 510(k) number K160773. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Yarlap II?
Yarlap II is a medical device that received FDA 510(k) clearance on 2016-05-04. The listed applicant is International Trade Group, Inc.. The 510(k) number is K160773.
When did Yarlap II receive FDA 510(k) clearance?
Yarlap II received FDA 510(k) clearance on 2016-05-04, under 510(k) number K160773.
Who is the listed applicant for Yarlap II?
The FDA 510(k) record lists International Trade Group, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Yarlap II?
The FDA product code for Yarlap II is KPI.
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。
列明International Trade Group, Inc.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：KPI）
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
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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