Vitra 2
K-Number: K191962 · 2019-12-05
ApplicantQuantel Medical
Decision Date2019-12-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Vitra 2 is a medical device manufactured by Quantel Medical. It received FDA 510(k) clearance on 2019-12-05 under approval number K191962. 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 Vitra 2?
Vitra 2 is a medical device that received FDA 510(k) clearance on 2019-12-05. It is manufactured by Quantel Medical. The 510(k) number is K191962.
When was Vitra 2 approved by the FDA?
Vitra 2 received FDA 510(k) clearance on 2019-12-05, under approval number K191962.
What company makes Vitra 2?
Vitra 2 is manufactured by Quantel Medical.
What is the FDA product code for Vitra 2?
The FDA product code for Vitra 2 is GEX. This falls under the Gastroenterology category.
Other Devices by Quantel Medical
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.