510(k) K863045

PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 by Cardiac Pacemakers, Inc. — Product Code KRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
August 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Programmer, Pacemaker
Device Class
Class III
Regulation Number
870.3700
Review Panel
CV
Submission Type