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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 K073261
Device Name VAR MONITOR
Applicant
Vortran Medical Technology 1, Inc.
21 Golden Land Ct.
Sacramento,  CA  95834
Applicant Contact JAMES LEE
Correspondent
Vortran Medical Technology 1, Inc.
21 Golden Land Ct.
Sacramento,  CA  95834
Correspondent Contact JAMES LEE
Regulation Number868.5925
Classification Product Code
BTL  
Date Received11/20/2007
Decision Date 05/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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