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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
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