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FDA 510(k)

NAPA LP-15 呼吸道压力监测仪

K号: K172284 · 2018-02-09

决定日期2018-02-09
产品代码CAP
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

NAPA LP-15 Airway Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Drw Medical, LLC. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K172284. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NAPA LP-15 Airway Pressure Monitor?

NAPA LP-15 Airway Pressure Monitor is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Drw Medical, LLC. The 510(k) number is K172284.

When did NAPA LP-15 Airway Pressure Monitor receive FDA 510(k) clearance?

NAPA LP-15 Airway Pressure Monitor received FDA 510(k) clearance on 2018-02-09, under 510(k) number K172284.

Who is the listed applicant for NAPA LP-15 Airway Pressure Monitor?

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

What is the FDA product code for NAPA LP-15 Airway Pressure Monitor?

The FDA product code for NAPA LP-15 Airway Pressure Monitor is CAP.

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。

相关器械(代码:CAP)

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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