SJM CONFIRM


Device Classification Name

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

510(k) Number K122161
Device Name SJM CONFIRM
Applicant
ST. JUDE MEDICAL
701 east evelyn avenue
sunnyvale, 
CA 
94086 -6527

Applicant Contact saket bhatt
Correspondent
ST. JUDE MEDICAL
701 east evelyn avenue
sunnyvale, 
CA 
94086 -6527

Correspodent Contact saket bhatt
Regulation Number 870.2800
Classification Product Code
MXC  
Date Received 07/20/2012
Decision Date 11/28/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No