FDA 510(k)

血压计（TMB-2092-G）

K号: K241351 · 2024-08-21

申请人Guangdong Transtek Medical Electronics Co., Ltd.

决定日期2024-08-21

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

Blood Pressure Monitor (TMB-2092-G) 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 2024-08-21 under 510(k) number K241351. 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 Blood Pressure Monitor (TMB-2092-G)?

Blood Pressure Monitor (TMB-2092-G) is a medical device that received FDA 510(k) clearance on 2024-08-21. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K241351.

When did Blood Pressure Monitor (TMB-2092-G) receive FDA 510(k) clearance?

Blood Pressure Monitor (TMB-2092-G) received FDA 510(k) clearance on 2024-08-21, under 510(k) number K241351.

Who is the listed applicant for Blood Pressure Monitor (TMB-2092-G)?

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 Blood Pressure Monitor (TMB-2092-G)?

The FDA product code for Blood Pressure Monitor (TMB-2092-G) is DXN.