EVO platform
K-Number: K160368 · 2016-04-05
ApplicantQuanta System Spa
Decision Date2016-04-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
EVO platform is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2016-04-05 under approval number K160368. 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 EVO platform?
EVO platform is a medical device that received FDA 510(k) clearance on 2016-04-05. It is manufactured by Quanta System Spa. The 510(k) number is K160368.
When was EVO platform approved by the FDA?
EVO platform received FDA 510(k) clearance on 2016-04-05, under approval number K160368.
What company makes EVO platform?
EVO platform is manufactured by Quanta System Spa.
What is the FDA product code for EVO platform?
The FDA product code for EVO platform 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.