510(k) K000812

NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) by Neurosoft, Inc. — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2000
Date Received
March 13, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type