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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 K061908
Device Name NICOLETONE SYSTEM V32 AMPLIFIER
Applicant
Viasys Neuro Care
800 Levanger Ln.
Stoughton,  WI  53589
Applicant Contact Gary Syring
Correspondent
Viasys Neuro Care
800 Levanger Ln.
Stoughton,  WI  53589
Correspondent Contact Gary Syring
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received07/05/2006
Decision Date 11/06/2006
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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