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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(K) Number K112858
Model 6055100A1
Device Name GENESIS TOUCH SYSTEM
Applicant
HONEYWELL HOMMED, LLC
3400 intertech dr.
suite 200
brookfield,  WI  53045
Contact claudia jackson
Regulation Number870.2910
Classification Product Code
DRG  
Date Received09/30/2011
Decision Date 01/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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