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FDA 510(k)

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 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 2018-10-02 under 510(k) 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. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K181867.

When did Deka Smartxide2 Trio receive FDA 510(k) clearance?

Deka Smartxide2 Trio received FDA 510(k) clearance on 2018-10-02, under 510(k) number K181867.

Who is the listed applicant for Deka Smartxide2 Trio?

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 Smartxide2 Trio?

The FDA product code for Deka Smartxide2 Trio is GEX. This falls under the Gastroenterology category.

Other records listing El.En Electronic Engineering Spa as applicant

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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.

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