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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name amplifier, physiological signal
510(k) Number K880773
Device Name THE VENUS SYSTEM
Applicant
NEUROSCIENTIFIC CORP.
139 FLORIDA ST.
FARMINGDALE,  NY  11735
Applicant Contact ALAN P SCHWARTZ
Correspondent
NEUROSCIENTIFIC CORP.
139 FLORIDA ST.
FARMINGDALE,  NY  11735
Correspondent Contact ALAN P SCHWARTZ
Regulation Number882.1835
Classification Product Code
GWL  
Date Received02/26/1988
Decision Date 08/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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