510(k) K880773

THE VENUS SYSTEM by Neuroscientific Corp. — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1988
Date Received
February 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type