FDA 510(k)

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K号: K172801 · 2017-10-18

决定日期2017-10-18

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

ECG SENTINEL System is the device name listed in this FDA 510(k) record. The listed applicant is Cardiomedix, Inc.. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K172801. 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 ECG SENTINEL System?

ECG SENTINEL System is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Cardiomedix, Inc.. The 510(k) number is K172801.

When did ECG SENTINEL System receive FDA 510(k) clearance?

ECG SENTINEL System received FDA 510(k) clearance on 2017-10-18, under 510(k) number K172801.

Who is the listed applicant for ECG SENTINEL System?

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

What is the FDA product code for ECG SENTINEL System?

The FDA product code for ECG SENTINEL System is DXH. This falls under the Hematology category.

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心电图 SENTRY 系统

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