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FDA 510(k)

SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER

K-Number: K072159 · 2007-12-27

ApplicantEl.En Electronic Engineering Spa
Decision Date2007-12-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER 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 2007-12-27 under 510(k) number K072159. 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 SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER?

SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER is a medical device that received FDA 510(k) clearance on 2007-12-27. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K072159.

When did SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER receive FDA 510(k) clearance?

SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER received FDA 510(k) clearance on 2007-12-27, under 510(k) number K072159.

Who is the listed applicant for SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER?

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 SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER?

The FDA product code for SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER 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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