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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
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 (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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