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FDA 510(k)

Compower CPR口罩带氧气端口，Compower CPR口罩不带氧气端口，Compower婴儿CPR口罩，Compower非重复呼吸阀（22mm/15mmOD），非重复呼吸阀（22mm/18.5mm）

K号: K171961 · 2017-11-17

申请人Xiamen Compower Medical Tech. Co., Ltd.
决定日期2017-11-17
产品代码CBP
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

Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Compower Medical Tech. Co., Ltd.. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K171961. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)?

Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Xiamen Compower Medical Tech. Co., Ltd.. The 510(k) number is K171961.

When did Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) receive FDA 510(k) clearance?

Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) received FDA 510(k) clearance on 2017-11-17, under 510(k) number K171961.

Who is the listed applicant for Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)?

The FDA 510(k) record lists Xiamen Compower Medical Tech. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)?

The FDA product code for Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) is CBP.

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Xiamen Compower Medical Tech. Co., Ltd.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。

K210288一次性手动复苏器

相关器械（代码：CBP）

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。

K241366QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)Dehas Medical Systems GmbHK234053F&P Optiflow流量分配器Fisher & Paykel Healthcare, Ltd.K210992Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic ASK192285CPR 面部护盾Firstar Healthcare Company Limited (Guangzhou)K173770OJR215 压力释放歧管Fisher & Paykel Healthcare LimitedK152521Seal Rite 非重复呼吸阀The Lifeguard Store, Inc.

官方来源

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