FDA 510(k)

Digital Blood Pressure Monitor (Arm Type)

K号: K231245 · 2023-11-22

申请人Guangdong Genial Technology Co., Ltd.

决定日期2023-11-22

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： --- 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 Blood Pressure Monitor (Arm Type) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Genial Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K231245. 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 Blood Pressure Monitor (Arm Type)?

Digital Blood Pressure Monitor (Arm Type) is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Guangdong Genial Technology Co., Ltd.. The 510(k) number is K231245.

When did Digital Blood Pressure Monitor (Arm Type) receive FDA 510(k) clearance?

Digital Blood Pressure Monitor (Arm Type) received FDA 510(k) clearance on 2023-11-22, under 510(k) number K231245.

Who is the listed applicant for Digital Blood Pressure Monitor (Arm Type)?

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

What is the FDA product code for Digital Blood Pressure Monitor (Arm Type)?

The FDA product code for Digital Blood Pressure Monitor (Arm Type) is DXN.

列明Guangdong Genial 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。

K240333可穿戴数字体温计（T31）K232678数字温度计，型号T28，T28L K231250Digital Blood Pressure Monitor K231243Finger Clip Pulse Oximeter

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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