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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 K122324
Device Name VPAP S-A
Applicant
RESMED LTD.
9001 spectrum center blvd.
san diego,  CA  92123
Applicant Contact jim cassi
Correspondent
RESMED LTD.
9001 spectrum center blvd.
san diego,  CA  92123
Correspodent Contact jim cassi
Regulation Number868.5895
Classification Product Code
MNS  
Date Received08/01/2012
Decision Date 11/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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