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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, non-life-supporting
510(k) Number K113288
Device Name VPAP ST-A
Original Applicant
RESMED LTD.
9001 spectrum center blvd.
san diego,  CA  92123
Original Contact david d'cruz
Regulation Number868.5895
Classification Product Code
MNS  
Date Received11/07/2011
Decision Date 03/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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