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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source Localization Software For Electroencephalograph Or Magnetoencephalograph
510(k) Number K980477
Device Name IMAGE VUE EEG
Applicant
SAM TECHNOLOGY, INC.
KAMM & ASSOCIATES
P.O. BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
SAM TECHNOLOGY, INC.
KAMM & ASSOCIATES
P.O. BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number882.1400
Classification Product Code
OLX  
Date Received02/06/1998
Decision Date 08/06/1998
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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