VORTRAN GO2VENT With PEEP Valve

Ventilator, Emergency, Powered (resuscitator)

Vortran Medical Technology 1, Inc.

The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Vortran Go2vent With Peep Valve.

Pre-market Notification Details

Device IDK202219
510k NumberK202219
Device Name:VORTRAN GO2VENT With PEEP Valve
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant Vortran Medical Technology 1, Inc. 21 Goldenland Court, Suite 100 Sacramento,  CA  95834
ContactAdam Palumbo
CorrespondentAdam Palumbo
Vortran Medical Technology 1, Inc. 21 Goldenland Court, Suite 100 Sacramento,  CA  95834
Product CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-06
Decision Date2021-02-11

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