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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automatic Event Detection Software For Full-Montage Electroencephalograph
510(k) Number K950117
Device Name PERSYST SPIKE DETECTOR
Applicant
Persyst Consulting Services, Inc.
605 E St.
Belmar,  NJ  07719
Applicant Contact SCOTT B WILSON
Correspondent
Persyst Consulting Services, Inc.
605 E St.
Belmar,  NJ  07719
Correspondent Contact SCOTT B WILSON
Regulation Number882.1400
Classification Product Code
OMB  
Date Received01/11/1995
Decision Date 04/05/1995
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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