FDA 510(k)U80系列上臂式电子血压计
K号: K160019 · 2016-04-22
决定日期2016-04-22
产品代码DXN
咨询委员会CV
请注意，由于原文未提供具体内容，以下是一个示例翻译：
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产品名称：[产品名称]
公司名称：[公司名称]
FDA批准号：[FDA批准号]
510(k)申请号：[510(k)申请号]
PMA申请号：[PMA申请号]
临床试验注册号：[NCT]
PubMed ID：[PMID]
产品标识符：[标识符]
产品URL：[URL]
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请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同
器械摘要
U80 Series Upper Arm Electronic Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Urion Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K160019. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the U80 Series Upper Arm Electronic Blood Pressure Monitor?
U80 Series Upper Arm Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is Shenzhen Urion Technology Co., Ltd.. The 510(k) number is K160019.
When did U80 Series Upper Arm Electronic Blood Pressure Monitor receive FDA 510(k) clearance?
U80 Series Upper Arm Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2016-04-22, under 510(k) number K160019.
Who is the listed applicant for U80 Series Upper Arm Electronic Blood Pressure Monitor?
The FDA 510(k) record lists Shenzhen Urion Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for U80 Series Upper Arm Electronic Blood Pressure Monitor?
The FDA product code for U80 Series Upper Arm Electronic Blood Pressure Monitor is DXN.
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Shenzhen Urion Technology Co., 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。
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相关器械（代码：DXN）
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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