FDA 510(k)

患者监护仪，型号 LM-8、LM-10、LM-12 和 LM-15

K号: K221879 · 2022-08-10

决定日期2022-08-10

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

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 is the device name listed in this FDA 510(k) record. The listed applicant is Caf Medical Solutions, Inc.. It received FDA 510(k) clearance on 2022-08-10 under 510(k) number K221879. 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 Patient Monitor, models LM-8, LM-10, LM-12 and LM-15?

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 is a medical device that received FDA 510(k) clearance on 2022-08-10. The listed applicant is Caf Medical Solutions, Inc.. The 510(k) number is K221879.

When did Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 receive FDA 510(k) clearance?

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 received FDA 510(k) clearance on 2022-08-10, under 510(k) number K221879.

Who is the listed applicant for Patient Monitor, models LM-8, LM-10, LM-12 and LM-15?

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

What is the FDA product code for Patient Monitor, models LM-8, LM-10, LM-12 and LM-15?

The FDA product code for Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 is MHX.

列明Caf Medical Solutions, 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。

K221616患者监护仪，型号 LMPLUS-12、LMPLUS-15 和 LMPLUS-17 K220362LE-12CH

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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