FDA 510(k)

Digital Automatic Wrist Blood Pressure Monitor MD4300

K号: K171379 · 2018-04-10

申请人Grandway Technology (Shenzhen) Limited

决定日期2018-04-10

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： --- 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] --- 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

Digital Automatic Wrist Blood Pressure Monitor MD4300 is the device name listed in this FDA 510(k) record. The listed applicant is Grandway Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2018-04-10 under 510(k) number K171379. 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 Digital Automatic Wrist Blood Pressure Monitor MD4300?

Digital Automatic Wrist Blood Pressure Monitor MD4300 is a medical device that received FDA 510(k) clearance on 2018-04-10. The listed applicant is Grandway Technology (Shenzhen) Limited. The 510(k) number is K171379.

When did Digital Automatic Wrist Blood Pressure Monitor MD4300 receive FDA 510(k) clearance?

Digital Automatic Wrist Blood Pressure Monitor MD4300 received FDA 510(k) clearance on 2018-04-10, under 510(k) number K171379.

Who is the listed applicant for Digital Automatic Wrist Blood Pressure Monitor MD4300?

The FDA 510(k) record lists Grandway Technology (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Automatic Wrist Blood Pressure Monitor MD4300?

The FDA product code for Digital Automatic Wrist Blood Pressure Monitor MD4300 is DXN.

列明Grandway Technology (Shenzhen) Limited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。

K191593Digital Automatic Blood Pressure Monitor MD36 Series K163648Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series K163679Digital Automatic Blood Pressure Monitor MD3600 K163113Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series

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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官方来源

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