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FDA 510(k)

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)

K-Number: K180193 · 2018-02-21

ApplicantEl.En Electronic Engineering Spa
Decision Date2018-02-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) is a medical device manufactured by El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2018-02-21 under approval number K180193. 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 SMARTXIDE Family (Smartxide Touch, Smartxide Punto)?

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) is a medical device that received FDA 510(k) clearance on 2018-02-21. It is manufactured by El.En Electronic Engineering Spa. The 510(k) number is K180193.

When was DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) approved by the FDA?

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) received FDA 510(k) clearance on 2018-02-21, under approval number K180193.

What company makes DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)?

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) is manufactured by El.En Electronic Engineering Spa.

What is the FDA product code for DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)?

The FDA product code for DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) 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.

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