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FDA 510(k)

The NOxBOXi 氧化氮输送系统

K号: K201339 · 2020-06-19

申请人Praxair, Inc.
决定日期2020-06-19
产品代码MRN
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

The NOxBOXi Nitric Oxide Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Praxair, Inc.. It received FDA 510(k) clearance on 2020-06-19 under 510(k) number K201339. The device is classified under product code MRN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the The NOxBOXi Nitric Oxide Delivery System?

The NOxBOXi Nitric Oxide Delivery System is a medical device that received FDA 510(k) clearance on 2020-06-19. The listed applicant is Praxair, Inc.. The 510(k) number is K201339.

When did The NOxBOXi Nitric Oxide Delivery System receive FDA 510(k) clearance?

The NOxBOXi Nitric Oxide Delivery System received FDA 510(k) clearance on 2020-06-19, under 510(k) number K201339.

Who is the listed applicant for The NOxBOXi Nitric Oxide Delivery System?

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

What is the FDA product code for The NOxBOXi Nitric Oxide Delivery System?

The FDA product code for The NOxBOXi Nitric Oxide Delivery System is MRN.

相关临床试验

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相关器械(代码:MRN)

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。

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