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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 K121932
Model HEM-7200-Z (BP742)
Device Name HEM-7200-Z (BP742)
Original Applicant
24301 woodsage drive
bonita springs,  FL  34134
Original Contact paul dryden
Regulation Number870.1130
Classification Product Code
Date Received07/02/2012
Decision Date 08/29/2012
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