Deka Smartxide2 Trio
K-Number: K181867 · 2018-10-02
ApplicantEl.En Electronic Engineering Spa
Decision Date2018-10-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Deka Smartxide2 Trio is a medical device manufactured by El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2018-10-02 under approval number K181867. 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.
Frequently Asked Questions
What is the Deka Smartxide2 Trio?
Deka Smartxide2 Trio is a medical device that received FDA 510(k) clearance on 2018-10-02. It is manufactured by El.En Electronic Engineering Spa. The 510(k) number is K181867.
When was Deka Smartxide2 Trio approved by the FDA?
Deka Smartxide2 Trio received FDA 510(k) clearance on 2018-10-02, under approval number K181867.
What company makes Deka Smartxide2 Trio?
Deka Smartxide2 Trio is manufactured by El.En Electronic Engineering Spa.
What is the FDA product code for Deka Smartxide2 Trio?
The FDA product code for Deka Smartxide2 Trio is GEX. This falls under the Gastroenterology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.