510(k) K093211

CARECENTER MD by Cardiac Science Corporation — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2010
Date Received
October 13, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type