FDA 510(k)

Medicalgorithmics Unified Cardiac Rehabilitation System

K号: K173969 · 2018-07-11

决定日期2018-07-11

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

Medicalgorithmics Unified Cardiac Rehabilitation System 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 2018-07-11 under 510(k) number K173969. 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 Medicalgorithmics Unified Cardiac Rehabilitation System?

Medicalgorithmics Unified Cardiac Rehabilitation System is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Medicalgorithmics S.A.. The 510(k) number is K173969.

When did Medicalgorithmics Unified Cardiac Rehabilitation System receive FDA 510(k) clearance?

Medicalgorithmics Unified Cardiac Rehabilitation System received FDA 510(k) clearance on 2018-07-11, under 510(k) number K173969.

Who is the listed applicant for Medicalgorithmics Unified Cardiac Rehabilitation System?

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 Medicalgorithmics Unified Cardiac Rehabilitation System?

The FDA product code for Medicalgorithmics Unified Cardiac Rehabilitation System is DSI.

列明Medicalgorithmics S.A.为申报人的其他记录

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