FDA 510(k)

“BRAXX” 食管近距离放射治疗施源器

K号: K183332 · 2019-04-16

决定日期2019-04-16

产品代码JAQ

咨询委员会RA

决定实质等同

器械摘要

“BRAXX” Esophageal Brachytherapy Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Braxx Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-04-16 under 510(k) number K183332. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the “BRAXX” Esophageal Brachytherapy Applicator?

“BRAXX” Esophageal Brachytherapy Applicator is a medical device that received FDA 510(k) clearance on 2019-04-16. The listed applicant is Braxx Biotech Co., Ltd.. The 510(k) number is K183332.

When did “BRAXX” Esophageal Brachytherapy Applicator receive FDA 510(k) clearance?

“BRAXX” Esophageal Brachytherapy Applicator received FDA 510(k) clearance on 2019-04-16, under 510(k) number K183332.

Who is the listed applicant for “BRAXX” Esophageal Brachytherapy Applicator?

The FDA 510(k) record lists Braxx Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for “BRAXX” Esophageal Brachytherapy Applicator?

The FDA product code for “BRAXX” Esophageal Brachytherapy Applicator is JAQ.

列明Braxx Biotech Co., Ltd.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。

K243045“BRAXX” 食管近距离放射治疗施源器（型号：BKMI2001，BKMI2002）

官方来源

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