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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, emergency, powered (resuscitator)
510(k) Number K202219
Device Name VORTRAN GO2VENT with PEEP Valve
Applicant
Vortran Medical Technology 1, Inc.
21 Goldenland Court, Suite 100
Sacramento,  CA  95834
Applicant Contact Adam Palumbo
Correspondent
Vortran Medical Technology 1, Inc.
21 Goldenland Court, Suite 100
Sacramento,  CA  95834
Correspondent Contact Adam Palumbo
Regulation Number868.5925
Classification Product Code
BTL  
Date Received08/06/2020
Decision Date 02/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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