Deka Luxea
K-Number: K192539 · 2019-12-16
ApplicantEl.En Electronic Engineering Spa
Decision Date2019-12-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Deka Luxea is a medical device manufactured by El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2019-12-16 under approval number K192539. 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 Luxea?
Deka Luxea is a medical device that received FDA 510(k) clearance on 2019-12-16. It is manufactured by El.En Electronic Engineering Spa. The 510(k) number is K192539.
When was Deka Luxea approved by the FDA?
Deka Luxea received FDA 510(k) clearance on 2019-12-16, under approval number K192539.
What company makes Deka Luxea?
Deka Luxea is manufactured by El.En Electronic Engineering Spa.
What is the FDA product code for Deka Luxea?
The FDA product code for Deka Luxea 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.