FDA 510(k)

Source 生产与设备公司 Model M14 192Iridium 近距离放射源

K号: K162573 · 2016-11-04

申请人Source Production and Equipment Co., Inc.

决定日期2016-11-04

产品代码KXK

咨询委员会RA

决定实质等同

器械摘要

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is the device name listed in this FDA 510(k) record. The listed applicant is Source Production and Equipment Co., Inc.. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K162573. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source?

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Source Production and Equipment Co., Inc.. The 510(k) number is K162573.

When did Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source receive FDA 510(k) clearance?

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162573.

Who is the listed applicant for Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source?

The FDA 510(k) record lists Source Production and Equipment Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source?

The FDA product code for Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is KXK.

列明Source Production and Equipment Co., Inc.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。

K161396SPEC模型M23 K161395SPEC模型M13

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