FDA 510(k)

Infinity Acute Care System (IACS) Monitoring System

K号: K203088 · 2022-02-01

决定日期2022-02-01

产品代码MHX

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

Infinity Acute Care System (IACS) Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-02-01 under 510(k) number K203088. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Infinity Acute Care System (IACS) Monitoring System?

Infinity Acute Care System (IACS) Monitoring System is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K203088.

When did Infinity Acute Care System (IACS) Monitoring System receive FDA 510(k) clearance?

Infinity Acute Care System (IACS) Monitoring System received FDA 510(k) clearance on 2022-02-01, under 510(k) number K203088.

Who is the listed applicant for Infinity Acute Care System (IACS) Monitoring System?

FDA 510(k)记录中列出Draeger Medical Systems, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Infinity Acute Care System (IACS) Monitoring System?

The FDA product code for Infinity Acute Care System (IACS) Monitoring System is MHX.

列明Draeger Medical Systems, 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。

K260579Infinity® 急诊护理系统（IACS）- VG8.1 K243606Babyroo TN300 K240312Infinity CentralStation Wide K233834Infinity Gateway Suite K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+K230278Babyroo TN300

查看所有 12 个设备 →

相关器械（代码：MHX）

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。

K260656Carescape ONE；Carescape Dock F0；TruSignal ECG MM；TruSignal PRES MM；TruSignal TEMP MM；TruSignal SpO2 MM 1.8M；TruSignal SpO2 MM 3.0MGE Healthcare Finland Oy K260343Carescape Canvas 1000；Carescape Canvas智能显示屏GE Healthcare Finland Oy K260579Infinity® 急诊护理系统（IACS）- VG8.1Draeger Medical Systems, Inc.K251508遥测监测仪（iT30，iT50）Edan Instruments, Inc.K253277Monitor B105M；Monitor B125M；Monitor B155M；Monitor B105P；Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM和附件Masimo Corporation

官方来源

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