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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K182112
Device Name Sense System with IBT Electrodes
Applicant
Infinite Biomedical Technologies, LLC
8 Market Place
Suite 500
Baltimore,  MD  21202
Applicant Contact Rahul Kaliki
Correspondent
Infinite Biomedical Technologies, LLC
8 Market Place
Suite 500
Baltimore,  MD  21202
Correspondent Contact Rahul Kaliki
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
IQZ  
Date Received08/06/2018
Decision Date 10/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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