FDA 510(k)

统一心律失常诊断系统智能ECG IV

K号: K193104 · 2020-04-09

决定日期2020-04-09

产品代码DSI

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

Unified Arrhythmia Diagnostic System PocketECG IV is the device name listed in this FDA 510(k) record. The listed applicant is Medicalgorithmics S.A.. It received FDA 510(k) clearance on 2020-04-09 under 510(k) number K193104. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Unified Arrhythmia Diagnostic System PocketECG IV?

Unified Arrhythmia Diagnostic System PocketECG IV is a medical device that received FDA 510(k) clearance on 2020-04-09. The listed applicant is Medicalgorithmics S.A.. The 510(k) number is K193104.

When did Unified Arrhythmia Diagnostic System PocketECG IV receive FDA 510(k) clearance?

Unified Arrhythmia Diagnostic System PocketECG IV received FDA 510(k) clearance on 2020-04-09, under 510(k) number K193104.

Who is the listed applicant for Unified Arrhythmia Diagnostic System PocketECG IV?

The FDA 510(k) record lists Medicalgorithmics S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unified Arrhythmia Diagnostic System PocketECG IV?

The FDA product code for Unified Arrhythmia Diagnostic System PocketECG IV is DSI.

列明Medicalgorithmics S.A.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。

K253141DeepRhythmAI K250932DeepRhythmAI K241197DeepRhythmAI K232161DeepRhythm Platform K210822DeepRhythmAI K210758Q 补片

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