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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K143152
Device Name TM-ABI system
Applicant
Ld Technology, LLC
100 N. Biscayne Blvd. Suite 502
Miami,  FL  33132
Applicant Contact Albert Maarek
Correspondent
Ld Technology, LLC
100 N. Biscayne Blvd. Suite 502
Miami,  FL  33132
Correspondent Contact Albert Maarek
Regulation Number870.2780
Classification Product Code
JOM  
Date Received11/03/2014
Decision Date 07/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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