SJM CONFIRM IMPLANTABLE CARDIAC MONITOR


Device Classification Name

recorder,event,implantable cardiac,(without arrhythmia detection)

510(k) Number K122090
Device Name SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
Applicant
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar, 
CA 
91342

Applicant Contact plessy paul
Correspondent
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar, 
CA 
91342

Correspodent Contact plessy paul
Regulation Number 870.2800
Classification Product Code
MXC  
Subsequent Product Codes
DSH   DXH  
Date Received 07/16/2012
Decision Date 11/15/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No