THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR


Device Classification Name

detector and alarm, arrhythmia

510(k) Number K103706
Device Name THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
Applicant
APPLIED CARDIAC SYSTEMS, INC.
22912 el pacifico dr
laguna hills, 
CA 
92653

Applicant Contact r. ben ghadimi
Correspondent
APPLIED CARDIAC SYSTEMS, INC.
22912 el pacifico dr
laguna hills, 
CA 
92653

Correspodent Contact r. ben ghadimi
Regulation Number 870.1025
Classification Product Code
DSI  
Date Received 12/20/2010
Decision Date 08/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No