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FDA 510(k)

Life Scope PT BSM-1700系列，AY系列，数据采集单元，LIFE SCOPE BSM 6000系列床旁监护系统，Nihon Kohden CSM-1901床旁监护系统

K号: K213316 · 2021-12-29

申请人Nihon Kohden Corporation
决定日期2021-12-29
产品代码KOI
咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同

器械摘要

Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corporation. It received FDA 510(k) clearance on 2021-12-29 under 510(k) number K213316. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM?

Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2021-12-29. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K213316.

When did Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM receive FDA 510(k) clearance?

Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM received FDA 510(k) clearance on 2021-12-29, under 510(k) number K213316.

Who is the listed applicant for Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM?

FDA 510(k)记录中列出Nihon Kohden Corporation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 Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM?

The FDA product code for Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM is KOI.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Nihon Kohden Corporation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。

K251641GF-310R 多气体单元（GF-310R）K260747YP-710T系列血压计袖带；YP-840T系列一次性袖带K251366EEG-1260A Neurofax系统（EEG-1260A）；JE-940A EEG放大器单元（JE-940A）；LS-940A光刺激器（LS-940A）K243956TG-980P CO2 传感器套件 (TG-980P); TG-980P1 CO2 传感器套件 (TG-980P1)K223567CNS-2101 中央监测仪K220976Life Scope PT BSM-1700系列床旁监护仪

查看所有 19 个设备 →

相关器械（代码：KOI）

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。

K261098TetraGraph神经肌肉传导监测器（SEN 2015）配件：TetraSens（SEN 2012）TetraSens儿童（SEN 2013）TetraSensitive（SEN 2016）TetraHub（SEN 2017）Senzime ABK250887神经肌肉传导监测器TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbHK243339WiTOFIdmedK242525iTOF®Nerbio Medical Software Platforms, Inc.K220530Tetragraph神经肌肉传导监测器Senzime ABK220976Life Scope PT BSM-1700系列床旁监护仪Nihon Kohden Corporation

官方来源

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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。

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