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FDA 510(k)

Master-Frank N95 颗粒物呼吸器

K号: K172963 · 2018-04-04

申请人Master & Frank Enterprise Co., Ltd.
决定日期2018-04-04
产品代码MSH
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Master-Frank N95 Particulate Respirator is the device name listed in this FDA 510(k) record. The listed applicant is Master & Frank Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2018-04-04 under 510(k) number K172963. The device is classified under product code MSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Master-Frank N95 Particulate Respirator?

Master-Frank N95 Particulate Respirator is a medical device that received FDA 510(k) clearance on 2018-04-04. The listed applicant is Master & Frank Enterprise Co., Ltd.. The 510(k) number is K172963.

When did Master-Frank N95 Particulate Respirator receive FDA 510(k) clearance?

Master-Frank N95 Particulate Respirator received FDA 510(k) clearance on 2018-04-04, under 510(k) number K172963.

Who is the listed applicant for Master-Frank N95 Particulate Respirator?

The FDA 510(k) record lists Master & Frank Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Master-Frank N95 Particulate Respirator?

The FDA product code for Master-Frank N95 Particulate Respirator is MSH.

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：MSH）

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。

K233022Halyard Fluidshield 3 N95 颗粒物过滤呼吸器和手术口罩，带柔软衬里，橙色，常规和小号，Halyard Fluidshield 3 N95 颗粒物过滤呼吸器和手术口罩，带安全密封和柔软衬里，橙色，常规和小号，Halyard Fluidshield 2 N95 颗粒物过滤呼吸器和手术口罩，带柔软衬里，白色，常规和小号Owens & Minor (O&M) Halyard, Inc.K1711163M® VFlex® Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S3M HealthcareK160271N95 颗粒物呼吸器和手术口罩，型号 TN01-11 和 TN01-12San-M Package Co., Ltd.

官方来源

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