EVO Platform
K-Number: K192160 · 2019-09-06
ApplicantQuanta System Spa
Decision Date2019-09-06
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 2019-09-06 under approval number K192160. 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 2019-09-06. It is manufactured by Quanta System Spa. The 510(k) number is K192160.
When was EVO Platform approved by the FDA?
EVO Platform received FDA 510(k) clearance on 2019-09-06, under approval number K192160.
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.
Other Devices by Quanta System Spa
Related Devices (Code: GEX)
K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.
K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.
K163222Discovery Pico FamilyQuanta System Spa
K163009LithoQuanta System Spa
K162191NAVILAS Laser SystemOd-Os GmbH
K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.
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.