510(k) K151640

ELTRAC 471 by Enraf-Nonius, B.V. — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2015
Date Received
June 18, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type