510(k) K063602

AUTOPULSE RESUSCITATION SYSTEM MODEL100 by Zoll Circulation — Product Code DRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2006
Date Received
December 4, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Cardiac, External
Device Class
Class II
Regulation Number
870.5200
Review Panel
CV
Submission Type