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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 K171102
Device Name Ives MR Conditional Cup Electrode
Applicant
Ives Egg Solutions
25 Storey Ave., #118
Newburyport,  MA  01950
Applicant Contact John Ives
Correspondent
Ives Egg Solutions
25 Storey Ave., #118
Newburyport,  MA  01950
Correspondent Contact John Ives
Regulation Number882.1320
Classification Product Code
GXY  
Date Received04/13/2017
Decision Date 12/21/2017
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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