FDA 510(k)

三星心电图监测应用，带有不规则心律通知功能

K号: K230292 · 2023-05-02

决定日期2023-05-02

产品代码QDA

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

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K230292. The device is classified under product code QDA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification?

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K230292.

When did Samsung ECG Monitor Application with Irregular Heart Rhythm Notification receive FDA 510(k) clearance?

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification received FDA 510(k) clearance on 2023-05-02, under 510(k) number K230292.

Who is the listed applicant for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification?

FDA 510(k)记录将三星电子株式会社列为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification?

The FDA product code for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is QDA.

列明Samsung Electronics 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。

K260481GC85A K261187助听器功能 K261011睡眠呼吸暂停功能（v2.0）K242651GM85 K242478GF85（型号 GF85-3P，GF85-SP）K240909三星心电图应用 v 1.3 (ECG)

查看所有 26 个设备 →

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。