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FDA 510(k)

Puritan Bennett 840 Series Ventilator System

K号: K151252 · 2016-03-29

申请人Covidien LP
决定日期2016-03-29
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

Puritan Bennett 840 Series Ventilator System is the device name listed in this FDA 510(k) record. The listed applicant is Covidien LP. It received FDA 510(k) clearance on 2016-03-29 under 510(k) number K151252. 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 Puritan Bennett 840 Series Ventilator System?

Puritan Bennett 840 Series Ventilator System is a medical device that received FDA 510(k) clearance on 2016-03-29. The listed applicant is Covidien LP. The 510(k) number is K151252.

When did Puritan Bennett 840 Series Ventilator System receive FDA 510(k) clearance?

Puritan Bennett 840 Series Ventilator System received FDA 510(k) clearance on 2016-03-29, under 510(k) number K151252.

Who is the listed applicant for Puritan Bennett 840 Series Ventilator System?

FDA 510(k)记录显示Covidien LP为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Puritan Bennett 840 Series Ventilator System?

The FDA product code for Puritan Bennett 840 Series Ventilator System is CBK.

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。

列明Covidien LP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。

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。

官方来源

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