FDA 510(k)

TRACHEOBRONXANE™ DUMON®

K号: K243126 · 2024-10-29

决定日期2024-10-29

产品代码NWA

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

TRACHEOBRONXANE™ DUMON® is the device name listed in this FDA 510(k) record. The listed applicant is Novatech SA. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K243126. The device is classified under product code NWA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TRACHEOBRONXANE™ DUMON®?

TRACHEOBRONXANE™ DUMON® is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Novatech SA. The 510(k) number is K243126.

When did TRACHEOBRONXANE™ DUMON® receive FDA 510(k) clearance?

TRACHEOBRONXANE™ DUMON® received FDA 510(k) clearance on 2024-10-29, under 510(k) number K243126.

Who is the listed applicant for TRACHEOBRONXANE™ DUMON®?

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

What is the FDA product code for TRACHEOBRONXANE™ DUMON®?

The FDA product code for TRACHEOBRONXANE™ DUMON® is NWA.

列明Novatech SA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。

K242324DUTAU-NOVATECH®K170030NOVATECH TALCAIR K151832NOVATECH TALCAIR

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。