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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 K131568
Device Name SUDO PATH
Applicant
LD TECHNOLOGY LLC
100 N. BISCAYNE BLVD, STE 500
MIAMI,  FL  33132
Applicant Contact ALBERT MAAREK
Correspondent
LD TECHNOLOGY LLC
100 N. BISCAYNE BLVD, STE 500
MIAMI,  FL  33132
Correspondent Contact ALBERT MAAREK
Regulation Number882.1540
Classification Product Code
GZO  
Date Received05/30/2013
Decision Date 06/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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