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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Spectrum, Electroencephalogram Signal
510(k) Number K974718
Device Name PERSYST PRISM
Applicant
Persyst Development Corp.
316 Skyline Dr.
Prescott,  AZ  86303
Applicant Contact SCOTT B WILSON
Correspondent
Persyst Development Corp.
316 Skyline Dr.
Prescott,  AZ  86303
Correspondent Contact SCOTT B WILSON
Regulation Number882.1420
Classification Product Code
GWS  
Date Received12/17/1997
Decision Date 03/09/1998
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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