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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(k) Number K182292
Device Name VORTRAN APM-Plus
Applicant
Vortran Medical Technology 1, Inc.
21 Goldenland Ct., Suite 100
Sacramento,  CA  95834
Applicant Contact James Lee
Correspondent
Vortran Medical Technology 1, Inc.
21 Goldenland Ct., Suite 100
Sacramento,  CA  95834
Correspondent Contact James Lee
Regulation Number868.2600
Classification Product Code
CAP  
Date Received08/23/2018
Decision Date 09/18/2019
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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