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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K160956
Device Name LD-Oxi system
Applicant
Ld Technology, LLC
100n. Biscayne Blvd., Suite 500
Miami,  FL  33132
Applicant Contact Albert MAAREK
Correspondent
Ld Technology, LLC
100n. Biscayne Blvd., Suite 500
Miami,  FL  33132
Correspondent Contact Albert MAAREK
Regulation Number870.2300
Classification Product Code
MWI  
Date Received04/05/2016
Decision Date 07/06/2016
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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