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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K970703
Device Name GALILEO HALLEY
Applicant
Biosound Esaote, Inc.
8000 Castleway Dr.
Indianapolis,  IN  46250
Applicant Contact GERALD A RICHARDSON
Correspondent
Biosound Esaote, Inc.
8000 Castleway Dr.
Indianapolis,  IN  46250
Correspondent Contact GERALD A RICHARDSON
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received02/26/1997
Decision Date 05/19/1997
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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