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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 K110223
Device Name WAVEGUARD (TM) EEG CAP
Applicant
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
8870 RAVELLO CT
NAPLES,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
8870 RAVELLO CT
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number882.1320
Classification Product Code
GXY  
Date Received01/25/2011
Decision Date 06/29/2011
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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