FDA 510(k)

Guardian Angel Rx GA2000 数字生命体征监测系统

K号: K183067 · 2019-03-01

申请人Taiwan Aulisa Medical Devices Technologies, Inc.

决定日期2019-03-01

产品代码DQA

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

Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K183067. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System?

Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K183067.

When did Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System receive FDA 510(k) clearance?

Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System received FDA 510(k) clearance on 2019-03-01, under 510(k) number K183067.

Who is the listed applicant for Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System?

The FDA 510(k) record lists Taiwan Aulisa Medical Devices Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System?

The FDA product code for Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is DQA.

列明Taiwan Aulisa Medical Devices Technologies, Inc.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。

K233963Aulisa脉搏血氧仪模块（第2代）（GA-OM0007, GA-OM0008）K233956Aulisa婴儿脉搏血氧仪模块（第2代）（GA-OM0018）K240220Aulisa温度模块（TM0002）K203208Guardian Angel Rx GA2000 系列数字生命体征监测系统 K202497Aulisa多患者数字生命体征监测系统 K191207Guardian Angel Rx GA2001 数字生命体征监测系统

查看所有 9 个设备 →

相关器械（代码：DQA）

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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