510(k) K152952

E-Cath by PAJUNK GmbH Medizintechnologie — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2016
Date Received
October 6, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type