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FDA 510(k)

EMVERA DIOLUX

K-Number: K123257 · 2012-12-14

ApplicantEmvera Technologies, Inc.
Decision Date2012-12-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EMVERA DIOLUX is the device name listed in this FDA 510(k) record. The listed applicant is Emvera Technologies, Inc.. It received FDA 510(k) clearance on 2012-12-14 under 510(k) number K123257. 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 EMVERA DIOLUX?

EMVERA DIOLUX is a medical device that received FDA 510(k) clearance on 2012-12-14. The listed applicant is Emvera Technologies, Inc.. The 510(k) number is K123257.

When did EMVERA DIOLUX receive FDA 510(k) clearance?

EMVERA DIOLUX received FDA 510(k) clearance on 2012-12-14, under 510(k) number K123257.

Who is the listed applicant for EMVERA DIOLUX?

The FDA 510(k) record lists Emvera Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMVERA DIOLUX?

The FDA product code for EMVERA DIOLUX is GEX. This falls under the Gastroenterology category.

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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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