510(k) K911665

ESCORT 300 SERIES by Medical Data Electronics — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1991
Date Received
April 12, 1991
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