FDA 510(k)

Mac-Lab (AltiX AI.i)；CardioLab (AltiX AI.i)；ComboLab (AltiX AI.i)；MLCL 客户端软件 (AltiX AI.i)

K号: K243540 · 2024-12-12

申请人Ge Medical Systems Information Technologies, Inc.

决定日期2024-12-12

产品代码DQK

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

Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2024-12-12 under 510(k) number K243540. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)?

Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) is a medical device that received FDA 510(k) clearance on 2024-12-12. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K243540.

When did Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) receive FDA 510(k) clearance?

Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) received FDA 510(k) clearance on 2024-12-12, under 510(k) number K243540.

Who is the listed applicant for Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)?

FDA 510(k)记录将通用医疗系统信息技术有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)?

The FDA product code for Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) is DQK.

列明Ge Medical Systems Information 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。

K253277Monitor B105M；Monitor B125M；Monitor B155M；Monitor B105P；Monitor B125P K251670MAC 7 静息心电图分析系统 K242562Monitor B105M；Monitor B125M；Monitor B155M；Monitor B105P；Monitor B125P K233810Portrait VSM K234130Portrait® 移动监控解决方案包括： • Portrait® 中央查看器应用程序（Portrait CVAXB） • Portrait® 核心服务（Portrait CSSXB） • Portrait® 临床警报单元（Portrait CAU01） • Portrait® 移动患者监护仪硬件（Portrait HUBXB） • Portrait® 移动患者监护仪软件（Portrait HSWXB） • Portrait® 可穿戴脉搏血氧传感器（Portrait SpO2 P-SA01） • Portrait® 可穿戴脉搏血氧传感器（Portrait SpO2 P-SP01） • Portrait® 可穿戴脉搏血氧传感器（Portrait SpO2 P-）K231870CASE V7.0 心脏测试系统及 CardioSoft V7.0 心脏测试系统

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官方来源

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