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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 K933951
Device Name VIDEO EEG OPTION MODIFICATION
Applicant
ESAOTE BIOMEDICA SPA
7990 CASTLEWAY DR.
INDIANAPOLIS,  IN  46250
Applicant Contact WAYNE L NETHERCUTT
Correspondent
ESAOTE BIOMEDICA SPA
7990 CASTLEWAY DR.
INDIANAPOLIS,  IN  46250
Correspondent Contact WAYNE L NETHERCUTT
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received08/12/1993
Decision Date 02/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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