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FDA 510(k)

E-LIGHT LINE

K-Number: K092734 · 2010-09-20

ApplicantEspansione Marketing S.P.A
Decision Date2010-09-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

E-LIGHT LINE 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 2010-09-20 under 510(k) number K092734. 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 E-LIGHT LINE?

E-LIGHT LINE is a medical device that received FDA 510(k) clearance on 2010-09-20. The listed applicant is Espansione Marketing S.P.A. The 510(k) number is K092734.

When did E-LIGHT LINE receive FDA 510(k) clearance?

E-LIGHT LINE received FDA 510(k) clearance on 2010-09-20, under 510(k) number K092734.

Who is the listed applicant for E-LIGHT LINE?

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 E-LIGHT LINE?

The FDA product code for E-LIGHT LINE is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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 AGAINK070494EPI-C PLUS

Related Devices (Code: GEX)

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.

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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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