510(k) K012274

MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER by Medtronic Physio-Control Corp. — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2002
Date Received
July 19, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type