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FDA 510(k)

气体采样线，共挤出，2m/7ft，10/包，一次性/ 100/包，一次性，气体采样线，共挤出，2.5m/8ft，10/包，一次性，气体采样线，共挤出，3m/10ft，10/包，一次性/ 100/包，一次性，气体采样线，共挤出，6m/20ft，5/包，一次性

K号: K171678 · 2018-04-30

申请人Vyaire Medical, Inc.
决定日期2018-04-30
产品代码CCK
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

Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable is the device name listed in this FDA 510(k) record. The listed applicant is Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2018-04-30 under 510(k) number K171678. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable?

Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable is a medical device that received FDA 510(k) clearance on 2018-04-30. The listed applicant is Vyaire Medical, Inc.. The 510(k) number is K171678.

When did Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable receive FDA 510(k) clearance?

Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable received FDA 510(k) clearance on 2018-04-30, under 510(k) number K171678.

Who is the listed applicant for Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable?

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

What is the FDA product code for Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable?

The FDA product code for Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable is CCK.

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Vyaire Medical, 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。

K230915AirLife® 开放式氧疗面罩，AirLife® 开放式氧疗面罩+K231380AirLife DuoTherm® 加湿系统K201082LTV2系列呼吸机K211294多链X2心电图电缆和导线系统K200510Multi-LinkTM X2心电图适配器和导线K191273多链X2心电图和SpO2适配器

查看所有 9 个设备 →

相关器械（代码：CCK）

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）Nihon Kohden CorporationK261633视呼吸Affirm Medical Technologies II, LLCK253030Capnostream™35 便携式呼吸监测仪 (PM35MN)Covidien, LLCK250148医疗气体分析仪（AG200）Prior Care Science Technology, Ltd.K243956TG-980P CO2 传感器套件 (TG-980P); TG-980P1 CO2 传感器套件 (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 样品线；0184T CO2 样品线；0139 CO2 样品线；0182 CO2 样品线Barbaras Development, Inc.

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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