SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR


Device Classification Name

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

510(k) Number K081365
Device Name SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
Applicant
ST. JUDE MEDICAL
701 east evelyn avenue
sunnyvale, 
CA 
94086 -6527

Applicant Contact elizabeth e neely
Correspondent
ST. JUDE MEDICAL
701 east evelyn avenue
sunnyvale, 
CA 
94086 -6527

Correspodent Contact elizabeth e neely
Regulation Number 870.2800
Classification Product Code
MXC  
Subsequent Product Codes
DSH   DXH  
Date Received 05/15/2008
Decision Date 08/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls