510(k) K781678

DEFIBRILLATOR, MARK II by Ipco Corp. — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1978
Date Received
October 2, 1978
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