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FDA 510(k)

日立医電 NKV-550 系列呼吸机系统

K号: K231778 · 2024-03-01

申请人Nihon Kohden Orangemed, LLC
决定日期2024-03-01
产品代码CBK
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

Nihon Kohden NKV-550 Series Ventilator System is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Orangemed, LLC. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K231778. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nihon Kohden NKV-550 Series Ventilator System?

Nihon Kohden NKV-550 Series Ventilator System is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Nihon Kohden Orangemed, LLC. The 510(k) number is K231778.

When did Nihon Kohden NKV-550 Series Ventilator System receive FDA 510(k) clearance?

Nihon Kohden NKV-550 Series Ventilator System received FDA 510(k) clearance on 2024-03-01, under 510(k) number K231778.

Who is the listed applicant for Nihon Kohden NKV-550 Series Ventilator System?

The FDA 510(k) record lists Nihon Kohden Orangemed, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nihon Kohden NKV-550 Series Ventilator System?

The FDA product code for Nihon Kohden NKV-550 Series Ventilator System is CBK.

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

相关器械（代码：CBK）

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。

K253647Evita（V800）；Evita（V600）Draegerwerk AG & CO KgaaK252663Inbentus多用途Iconic Solutions by Murcia, SLK251888VPAP儿童面罩Hsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸A (ONIV117A)；F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸B (ONIV117B)；F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸C (ONIV117C)；F&P OptiNIV ONIV117-F医院通气全脸面罩带可选呼气过滤器与单肢电路兼容 - 尺寸A (ONIV117A-F)；F&P OptiNIV ONIV117-F医院通气全脸面罩Fisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

官方来源

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