VORTRAN GO2VENT with PEEP Valve
K-Number: K202219 · 2021-02-11
ApplicantVortran Medical Technology 1, Inc.
Decision Date2021-02-11
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
VORTRAN GO2VENT with PEEP Valve is a medical device manufactured by Vortran Medical Technology 1, Inc.. It received FDA 510(k) clearance on 2021-02-11 under approval number K202219. 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 with PEEP Valve?
VORTRAN GO2VENT with PEEP Valve is a medical device that received FDA 510(k) clearance on 2021-02-11. It is manufactured by Vortran Medical Technology 1, Inc.. The 510(k) number is K202219.
When was VORTRAN GO2VENT with PEEP Valve approved by the FDA?
VORTRAN GO2VENT with PEEP Valve received FDA 510(k) clearance on 2021-02-11, under approval number K202219.
What company makes VORTRAN GO2VENT with PEEP Valve?
VORTRAN GO2VENT with PEEP Valve is manufactured by Vortran Medical Technology 1, Inc..
What is the FDA product code for VORTRAN GO2VENT with PEEP Valve?
The FDA product code for VORTRAN GO2VENT with PEEP Valve is BTL.
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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.