FDA 510(k)

F&P NivairoTM RT046非通气孔医院全脸面罩，标准肘部版本

K号: K173060 · 2018-01-25

决定日期2018-01-25

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

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version is the device name listed in this FDA 510(k) record. The listed applicant is Fisher and Paykel Healthcare Limited. It received FDA 510(k) clearance on 2018-01-25 under 510(k) number K173060. 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 F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version?

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version is a medical device that received FDA 510(k) clearance on 2018-01-25. The listed applicant is Fisher and Paykel Healthcare Limited. The 510(k) number is K173060.

When did F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version receive FDA 510(k) clearance?

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version received FDA 510(k) clearance on 2018-01-25, under 510(k) number K173060.

Who is the listed applicant for F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version?

FDA 510(k)记录显示，Fisher and Paykel Healthcare Limited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 F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version?

The FDA product code for F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version is CBK.

列明Fisher and Paykel Healthcare Limited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。

K262268Optiflow 氧气套件（AA484J）K243583F&P Nova鼻罩 K233829Nova Micro Pillows Mask 小A型号（NVP1SA）；Nova Micro Pillows Mask 中A型号（NVP1MA）；Nova Micro Pillows Mask 大A型号（NVP1LA）；Nova Micro Pillows Mask Fit Pack/SML A型号（NVP1SMLA）；Nova Micro Pillows Mask 小睡眠实验室A型号（NVP1SSLA）；Nova Micro Pillows Mask 中睡眠实验室A型号（NVP1MSLA）；Nova Micro Pillows Mask 大睡眠实验室A型号（NVP1LSLA）；Nova Micro Pillows Mask Fit Pack睡眠实验室A型号（NVP1SMLSLA）K211560Airvo 超声雾化器适配器 K191624F&P Nivairo RT047带通气孔医院全脸面罩，防窒息阀版本 K173770OJR215 压力释放歧管

查看所有 9 个设备 →

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 Kgaa K252663Inbentus多用途Iconic Solutions by Murcia, SL K251888VPAP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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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。