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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 K113714
Model 25102
Device Name VPAP TX
Applicant
RESMED LTD.
9001 spectrum center blvd.
san diego,  CA  92123
Contact david d'cruz
Regulation Number868.5895
Classification Product Code
MNS  
Date Received12/19/2011
Decision Date 05/25/2012
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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