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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, measurement, blood-pressure, non-invasive
510(K) Number K113185
Model HBP-1300
Device Name MODEL HBP-1300
Applicant
OMRON HEALTHCARE, INC.
24301 woodsage drive
bonita springs,  FL  34134
Contact paul dryden
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/28/2011
Decision Date 01/27/2012
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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