FDA 510(k)

CareTaker 监测应用

K号: K213699 · 2022-03-30

决定日期2022-03-30

产品代码DXN

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

CareTaker Monitor App is the device name listed in this FDA 510(k) record. The listed applicant is Caretaker Medical, LLC. It received FDA 510(k) clearance on 2022-03-30 under 510(k) number K213699. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CareTaker Monitor App?

CareTaker Monitor App is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is Caretaker Medical, LLC. The 510(k) number is K213699.

When did CareTaker Monitor App receive FDA 510(k) clearance?

CareTaker Monitor App received FDA 510(k) clearance on 2022-03-30, under 510(k) number K213699.

Who is the listed applicant for CareTaker Monitor App?

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

What is the FDA product code for CareTaker Monitor App?

The FDA product code for CareTaker Monitor App is DXN.

列明Caretaker Medical, LLC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。

K181196Caretaker 远程显示应用程序和 Caretaker 软件库 K163255CareTaker 连续非侵入式血压监测仪，CareTaker 无线生命体征监测仪，CareTaker 生理监测仪 K151499CareTaker 连续非侵入式血压监测仪，CareTaker 无线生命体征监测仪

相关器械（代码：DXN）

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。

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官方来源

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