VORTRAN GO2VENT
K-Number: K162968 · 2017-04-10
ApplicantVortran Medical Technology 1, Inc.
Decision Date2017-04-10
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
VORTRAN GO2VENT is a medical device manufactured by Vortran Medical Technology 1, Inc.. It received FDA 510(k) clearance on 2017-04-10 under approval number K162968. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VORTRAN GO2VENT?
VORTRAN GO2VENT is a medical device that received FDA 510(k) clearance on 2017-04-10. It is manufactured by Vortran Medical Technology 1, Inc.. The 510(k) number is K162968.
When was VORTRAN GO2VENT approved by the FDA?
VORTRAN GO2VENT received FDA 510(k) clearance on 2017-04-10, under approval number K162968.
What company makes VORTRAN GO2VENT?
VORTRAN GO2VENT is manufactured by Vortran Medical Technology 1, Inc..
What is the FDA product code for VORTRAN GO2VENT?
The FDA product code for VORTRAN GO2VENT is BTL.
Other Devices by Vortran Medical Technology 1, Inc.
Related Devices (Code: BTL)
K161420MOVES SLCThornhill Research, Inc.
K173373SafeT T-Piece ResuscitatorVentlab, LLC
K182956Puffin Lite Infant Resuscitation SystemInternational Biomedical
K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KG
K202219VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc.
K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A
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.