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FDA 510(k)

LifePath 远程患者监护平台

K号: K211822 · 2022-02-03

决定日期2022-02-03
产品代码DRG
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

LifePath Remote Patient Monitoring Platform is the device name listed in this FDA 510(k) record. The listed applicant is Elastic Care Incorporated. It received FDA 510(k) clearance on 2022-02-03 under 510(k) number K211822. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LifePath Remote Patient Monitoring Platform?

LifePath Remote Patient Monitoring Platform is a medical device that received FDA 510(k) clearance on 2022-02-03. The listed applicant is Elastic Care Incorporated. The 510(k) number is K211822.

When did LifePath Remote Patient Monitoring Platform receive FDA 510(k) clearance?

LifePath Remote Patient Monitoring Platform received FDA 510(k) clearance on 2022-02-03, under 510(k) number K211822.

Who is the listed applicant for LifePath Remote Patient Monitoring Platform?

The FDA 510(k) record lists Elastic Care Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LifePath Remote Patient Monitoring Platform?

The FDA product code for LifePath Remote Patient Monitoring Platform is DRG.

相关临床试验

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。

相关器械(代码:DRG)

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。

官方来源

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