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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(K) Number K122705
Device Name HUMICARE D900
Applicant
GRUNDLER GMBH
9001 spectrum center blvd
san diego,  CA  92123
Contact jim cassi
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/04/2012
Decision Date 05/21/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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