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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 K162968
Device Name VORTRAN GO2VENT
Applicant
Vortran Medical Technology 1, Inc.
21 Goldenland Ct.
#100
Sacramento,  CA  95834
Applicant Contact James Lee
Correspondent
Vortran Medical Technology 1, Inc.
21 Goldenland Ct.
#100
Sacramento,  CA  95834
Correspondent Contact James Lee
Regulation Number868.5925
Classification Product Code
BTL  
Date Received10/24/2016
Decision Date 04/10/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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