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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name index-generating electroencephalograph software
510(k) Number K060997
Device Name SNAP II EEG MONITOR
Applicant
EVEREST BIOMEDICAL INSTRUMENTS CO.
16690 SWINGLEY RIDGE RD.
SUITE 140
CHESTERFIELD,  MO  63017
Applicant Contact RANDALL J KROHN
Correspondent
EVEREST BIOMEDICAL INSTRUMENTS CO.
16690 SWINGLEY RIDGE RD.
SUITE 140
CHESTERFIELD,  MO  63017
Correspondent Contact RANDALL J KROHN
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
GXY   OMC   ORT  
Date Received04/10/2006
Decision Date 06/15/2006
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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