FDA 510(k)

Transtek血压计；Welch Allyn 901123数字血压设备

K号: K181832 · 2019-04-09

申请人Guangdong Transtek Medical Electronics Co., Ltd.

决定日期2019-04-09

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

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-04-09 under 510(k) number K181832. 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 Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device?

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device is a medical device that received FDA 510(k) clearance on 2019-04-09. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K181832.

When did Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device receive FDA 510(k) clearance?

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device received FDA 510(k) clearance on 2019-04-09, under 510(k) number K181832.

Who is the listed applicant for Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device?

The FDA 510(k) record lists Guangdong Transtek Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device?

The FDA product code for Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device is DXN.

列明Guangdong Transtek Medical Electronics 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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