FDA 510(k)

SPINEL 12HD 干预性荧光透视移动 X 射线系统

K号: K163140 · 2017-05-26

决定日期2017-05-26

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Gemss Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K163140. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System?

SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Gemss Medical Systems Co., Ltd.. The 510(k) number is K163140.

When did SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System receive FDA 510(k) clearance?

SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System received FDA 510(k) clearance on 2017-05-26, under 510(k) number K163140.

Who is the listed applicant for SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System?

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

What is the FDA product code for SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System?

The FDA product code for SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System is OWB.

列明Gemss Medical Systems 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。

K160065GEMSS 医疗系统手术移动式荧光透视X射线系统

官方来源

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