FDA 510(k)

GME LinScan Lite 808激光系统

K号: K180518 · 2018-07-23

决定日期2018-07-23

产品代码GEX

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决定实质等同

器械摘要

GME LinScan Lite 808 Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Gme German Medical Engineering GmbH. It received FDA 510(k) clearance on 2018-07-23 under 510(k) number K180518. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the GME LinScan Lite 808 Laser System?

GME LinScan Lite 808 Laser System is a medical device that received FDA 510(k) clearance on 2018-07-23. The listed applicant is Gme German Medical Engineering GmbH. The 510(k) number is K180518.

When did GME LinScan Lite 808 Laser System receive FDA 510(k) clearance?

GME LinScan Lite 808 Laser System received FDA 510(k) clearance on 2018-07-23, under 510(k) number K180518.

Who is the listed applicant for GME LinScan Lite 808 Laser System?

The FDA 510(k) record lists Gme German Medical Engineering GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GME LinScan Lite 808 Laser System?

The FDA product code for GME LinScan Lite 808 Laser System is GEX. This falls under the Gastroenterology category.

列明Gme German Medical Engineering GmbH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。

K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm K203054FlexSys K192269TwinScan 808/755 激光系统

官方来源

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