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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Galvanic Skin Response Measurement
510(k) Number K152216
Device Name SudoC
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 Number882.1540
Classification Product Code
GZO  
Date Received08/07/2015
Decision Date 09/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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