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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 K041473
Device Name VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
Applicant
VORTRAN MEDICAL TECHNOLOGY 1, INC.
1804 TRIBUTE RD., SUITE F
SACRAMENTO,  CA  95815
Applicant Contact JAMES LEE
Correspondent
VORTRAN MEDICAL TECHNOLOGY 1, INC.
1804 TRIBUTE RD., SUITE F
SACRAMENTO,  CA  95815
Correspondent Contact JAMES LEE
Regulation Number868.5925
Classification Product Code
BTL  
Date Received06/02/2004
Decision Date 07/15/2004
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
Recalls CDRH Recalls
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