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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 K113815
Device Name RESSCAN
Original Applicant
RESMED LTD.
9001 spectrum center blvd.
san diego,  CA  92123
Original Contact david d'cruz
Regulation Number868.5895
Classification Product Code
MNS  
Subsequent Product Codes
BZD   MNT  
Date Received12/23/2011
Decision Date 03/27/2012
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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