FDA 510(k)

eCordum 心脏监护仪（eCordum CM）

K号: K193296 · 2020-10-30

决定日期2020-10-30

产品代码DXH

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

eCordum Cardiac Monitor (eCordum CM) is the device name listed in this FDA 510(k) record. The listed applicant is Ecordum, Inc.. It received FDA 510(k) clearance on 2020-10-30 under 510(k) number K193296. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the eCordum Cardiac Monitor (eCordum CM)?

eCordum Cardiac Monitor (eCordum CM) is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Ecordum, Inc.. The 510(k) number is K193296.

When did eCordum Cardiac Monitor (eCordum CM) receive FDA 510(k) clearance?

eCordum Cardiac Monitor (eCordum CM) received FDA 510(k) clearance on 2020-10-30, under 510(k) number K193296.

Who is the listed applicant for eCordum Cardiac Monitor (eCordum CM)?

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

What is the FDA product code for eCordum Cardiac Monitor (eCordum CM)?

The FDA product code for eCordum Cardiac Monitor (eCordum CM) is DXH. This falls under the Hematology category.

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。

eCordum 心脏监护仪（eCordum CM）

器械摘要

常见问题

相关临床试验

相关器械（代码：DXH）

官方来源