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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accelerator, linear, medical
510(k) Number K112692
Device Name IDENTIFY
Original Applicant
HUMEDIQ GMBH
bahnhofstrabe 108
grafelfing,  GM 82166
Original Contact moritz hoyer
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/14/2012
Decision Date 08/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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