FDA 510(k)

QT心电图

K号: K220795 · 2022-09-26

决定日期2022-09-26

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

QT ECG is the device name listed in this FDA 510(k) record. The listed applicant is QT Medical, Inc.. It received FDA 510(k) clearance on 2022-09-26 under 510(k) number K220795. 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 QT ECG?

QT ECG is a medical device that received FDA 510(k) clearance on 2022-09-26. The listed applicant is QT Medical, Inc.. The 510(k) number is K220795.

When did QT ECG receive FDA 510(k) clearance?

QT ECG received FDA 510(k) clearance on 2022-09-26, under 510(k) number K220795.

Who is the listed applicant for QT ECG?

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

What is the FDA product code for QT ECG?

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

列明QT Medical, 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。

K233521QT心电图 (QTERD100)K200722PCA-C1 系列患者电缆 K180157QT心电图

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。

器械摘要

常见问题

列明QT Medical, Inc.为申报人的其他记录

相关器械（代码：DXH）

官方来源