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FDA 510(k)

DEKA SMARTXIDE AND DELIVERY ACCESSORIES

K-Number: K113504 · 2013-02-01

ApplicantEl.En Electronic Engineering Spa
Decision Date2013-02-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEKA SMARTXIDE AND DELIVERY ACCESSORIES 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 2013-02-01 under 510(k) number K113504. 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 AND DELIVERY ACCESSORIES?

DEKA SMARTXIDE AND DELIVERY ACCESSORIES is a medical device that received FDA 510(k) clearance on 2013-02-01. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K113504.

When did DEKA SMARTXIDE AND DELIVERY ACCESSORIES receive FDA 510(k) clearance?

DEKA SMARTXIDE AND DELIVERY ACCESSORIES received FDA 510(k) clearance on 2013-02-01, under 510(k) number K113504.

Who is the listed applicant for DEKA SMARTXIDE AND DELIVERY ACCESSORIES?

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 AND DELIVERY ACCESSORIES?

The FDA product code for DEKA SMARTXIDE AND DELIVERY ACCESSORIES 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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