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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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