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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 K113264
Model VERISON 1.
Device Name ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)
Original Applicant
LD TECHNOLOGY LLC
100 biscayne blvd ste 502
miami,  FL  33132
Original Contact abbert maarek
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DQA   GZO  
Date Received11/04/2011
Decision Date 03/02/2012
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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