FDA 510(k)

CARESCAPE Canvas 1000，CARESCAPE Canvas智能显示屏，CARESCAPE Canvas D19，F2框架（F2-01）

K号: K223531 · 2023-04-06

决定日期2023-04-06

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

CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2023-04-06 under 510(k) number K223531. 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 CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)?

CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) is a medical device that received FDA 510(k) clearance on 2023-04-06. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K223531.

When did CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) receive FDA 510(k) clearance?

CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) received FDA 510(k) clearance on 2023-04-06, under 510(k) number K223531.

Who is the listed applicant for CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)?

FDA 510(k)记录显示GE Healthcare Finland Oy为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)?

The FDA product code for CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) is MHX.

列明GE Healthcare Finland Oy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。

K260656Carescape ONE；Carescape Dock F0；TruSignal ECG MM；TruSignal PRES MM；TruSignal TEMP MM；TruSignal SpO2 MM 1.8M；TruSignal SpO2 MM 3.0M K260343Carescape Canvas 1000；Carescape Canvas智能显示屏 K213336Carescape B850，E-musb K213181CARESCAPE B650，E-musb K213363CARESCAPE B450，E-musb K211171CARESCAPE 呼吸模块 E-sCO，E-sCOV，E-sCOVX，E-sCAiO，E-sCAiOV，E-sCAiOVX，E-sCAiOE，E-sCAiOVE 和配件

查看所有 13 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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。