FDA 510(k)

多链X2心电图电缆和导线系统

K号: K162432 · 2017-01-18

决定日期2017-01-18

产品代码DSA

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

Multi-Link X2 ECG Cable and Lead Wire System is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 2200, Inc.. It received FDA 510(k) clearance on 2017-01-18 under 510(k) number K162432. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Multi-Link X2 ECG Cable and Lead Wire System?

Multi-Link X2 ECG Cable and Lead Wire System is a medical device that received FDA 510(k) clearance on 2017-01-18. The listed applicant is Carefusion 2200, Inc.. The 510(k) number is K162432.

When did Multi-Link X2 ECG Cable and Lead Wire System receive FDA 510(k) clearance?

Multi-Link X2 ECG Cable and Lead Wire System received FDA 510(k) clearance on 2017-01-18, under 510(k) number K162432.

Who is the listed applicant for Multi-Link X2 ECG Cable and Lead Wire System?

The FDA 510(k) record lists Carefusion 2200, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multi-Link X2 ECG Cable and Lead Wire System?

The FDA product code for Multi-Link X2 ECG Cable and Lead Wire System is DSA.

列明Carefusion 2200, Inc.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。

K210324V. Mueller Cosgrove 弹性夹具，型号编号-CV1033，CV1061，CV1133，CV1161，CV1186 K163615Snowden-Pencer MicroLap 3mm Laparoscopic Instruments K160764AirLife 自动填充加湿室 K153554Genesis低温可重复使用刚性容器系统 K151036Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments

相关器械（代码：DSA）

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。

官方来源

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