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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 K020218
Device Name SNAP EEG MONITOR
Applicant
Nicolet Biomedical, Inc.
800 Levanger Ln.
Stoughton,  WI  53589
Applicant Contact Gary Syring
Correspondent
Nicolet Biomedical, Inc.
800 Levanger Ln.
Stoughton,  WI  53589
Correspondent Contact Gary Syring
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OMC   ORT  
Date Received01/22/2002
Decision Date 04/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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