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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K121705
Device Name GEO
Original Applicant
RESMED LTD.
9001 spectrum center blvd.
san diego,  CA  92123
Original Contact jim cassi
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/08/2012
Decision Date 10/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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