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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K060189
Device Name PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
Applicant
Ives Eeg Solutions, Inc.
6325 Rideau Valley Dr.
Manotick, Ontario,  CA K4M 1B3
Applicant Contact JOHN IVES
Correspondent
Ives Eeg Solutions, Inc.
6325 Rideau Valley Dr.
Manotick, Ontario,  CA K4M 1B3
Correspondent Contact JOHN IVES
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received01/24/2006
Decision Date 05/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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