FDA 510(k)

Radial Artery Compression Tourniquets

K号: K222182 · 2023-01-04

申请人Beijing Demax Medical Technology Co.,Ltd

决定日期2023-01-04

产品代码DXC

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

Radial Artery Compression Tourniquets is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Demax Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-01-04 under 510(k) number K222182. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Radial Artery Compression Tourniquets?

Radial Artery Compression Tourniquets is a medical device that received FDA 510(k) clearance on 2023-01-04. The listed applicant is Beijing Demax Medical Technology Co.,Ltd. The 510(k) number is K222182.

When did Radial Artery Compression Tourniquets receive FDA 510(k) clearance?

Radial Artery Compression Tourniquets received FDA 510(k) clearance on 2023-01-04, under 510(k) number K222182.

Who is the listed applicant for Radial Artery Compression Tourniquets?

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

What is the FDA product code for Radial Artery Compression Tourniquets?

The FDA product code for Radial Artery Compression Tourniquets is DXC.

列明Beijing Demax Medical 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。

K242248引入鞘套装 K222184引入鞘套装

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。