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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K081670
Device Name THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK
Applicant
CARDINAL HEALTH 207, INC.
22745 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Applicant Contact ANDRE VON MULLER
Correspondent
CARDINAL HEALTH 207, INC.
22745 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Correspondent Contact ANDRE VON MULLER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/13/2008
Decision Date 10/09/2008
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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