FDA 510(k)

GME LinScan Lite 808 Laser System

Número K: K180518 · 2018-07-23

RequerenteGme German Medical Engineering GmbH

Data da decisão2018-07-23

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Gme German Medical Engineering GmbH como candidato(a)

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