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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 K140412
Device Name ANS1 SOFTWARE
Applicant
Ld Technology, LLC
100 Biscayne Blvd. Suite 502
Miami,  FL  33132
Applicant Contact ALBERT MAAREK
Correspondent
Ld Technology, LLC
100 Biscayne Blvd. Suite 502
Miami,  FL  33132
Correspondent Contact ALBERT MAAREK
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DQA   GZO  
Date Received02/18/2014
Decision Date 05/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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