510(k) K990015

ELECTRODE NEEDLES by Technomed Europe — Product Code IKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1999
Date Received
January 4, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle, Diagnostic Electromyograph
Device Class
Class II
Regulation Number
890.1385
Review Panel
NE
Submission Type