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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, electrical, evoked response
510(k) Number K861900
Device Name LIFESCAN EVOKED POTENTIAL SYSTEM
Applicant
NEUROMETRICS
5720 OBERLIN DR.
SAN DIEGO,  CA  92121
Applicant Contact PAUL VERDUCHI
Correspondent
NEUROMETRICS
5720 OBERLIN DR.
SAN DIEGO,  CA  92121
Correspondent Contact PAUL VERDUCHI
Regulation Number882.1870
Classification Product Code
GWF  
Date Received05/16/1986
Decision Date 08/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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