FDA 510(k)

Med-link 手腕式数字血压计，Med-link 上臂式数字血压计

K号: K181154 · 2019-08-02

申请人Shenzhen Med-Link Electronics Tech Co., Ltd.

决定日期2019-08-02

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

Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K181154. 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 Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor?

Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K181154.

When did Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor receive FDA 510(k) clearance?

Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor received FDA 510(k) clearance on 2019-08-02, under 510(k) number K181154.

Who is the listed applicant for Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor?

The FDA 510(k) record lists Shenzhen Med-Link Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor?

The FDA product code for Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor is DXN.

列明Shenzhen Med-Link Electronics Tech 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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