FDA 510(k)

FlexSys

K号: K203054 · 2021-03-05

决定日期2021-03-05

产品代码GEX

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决定实质等同

器械摘要

FlexSys 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 2021-03-05 under 510(k) number K203054. 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 FlexSys?

FlexSys is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Gme German Medical Engineering GmbH. The 510(k) number is K203054.

When did FlexSys receive FDA 510(k) clearance?

FlexSys received FDA 510(k) clearance on 2021-03-05, under 510(k) number K203054.

Who is the listed applicant for FlexSys?

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 FlexSys?

The FDA product code for FlexSys 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 K192269TwinScan 808/755 激光系统 K180518GME LinScan Lite 808激光系统

官方来源

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