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FDA 510(k)

EPI-C PLUS

K-Number: K070494 · 2007-05-01

ApplicantEspansione Marketing S.P.A
Decision Date2007-05-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPI-C PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Espansione Marketing S.P.A. It received FDA 510(k) clearance on 2007-05-01 under 510(k) number K070494. 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 EPI-C PLUS?

EPI-C PLUS is a medical device that received FDA 510(k) clearance on 2007-05-01. The listed applicant is Espansione Marketing S.P.A. The 510(k) number is K070494.

When did EPI-C PLUS receive FDA 510(k) clearance?

EPI-C PLUS received FDA 510(k) clearance on 2007-05-01, under 510(k) number K070494.

Who is the listed applicant for EPI-C PLUS?

The FDA 510(k) record lists Espansione Marketing S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPI-C PLUS?

The FDA product code for EPI-C PLUS is GEX. This falls under the Gastroenterology category.

Other records listing Espansione Marketing S.P.A as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K124064YOUNG AGAINK092734E-LIGHT LINE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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