FDA 510(k)

DEKA SMARTXIDE ULTRASPEED

Número K: K172363 · 2017-11-17

RequerenteEl.En Electronic Engineering Spa

Data da decisão2017-11-17

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DEKA SMARTXIDE ULTRASPEED is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K172363. 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 DEKA SMARTXIDE ULTRASPEED?

DEKA SMARTXIDE ULTRASPEED is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K172363.

When did DEKA SMARTXIDE ULTRASPEED receive FDA 510(k) clearance?

DEKA SMARTXIDE ULTRASPEED received FDA 510(k) clearance on 2017-11-17, under 510(k) number K172363.

Who is the listed applicant for DEKA SMARTXIDE ULTRASPEED?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA SMARTXIDE ULTRASPEED?

The FDA product code for DEKA SMARTXIDE ULTRASPEED is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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