510(k) K850077

MEDTRONIC 5311 PACING SYSTEM ANALYZER by Medtronic Vascular — Product Code DTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1985
Date Received
January 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Pacemaker Generator Function
Device Class
Class II
Regulation Number
870.3630
Review Panel
CV
Submission Type