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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
Recalls CDRH Recalls
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