PACEART OPTIMA SYSTEM SOFTWARE


Device Classification Name

analyzer, pacemaker generator function, indirect

510(k) Number K110693
Device Name PACEART OPTIMA SYSTEM SOFTWARE
Applicant
MEDTRONIC, INC.
8200 coral sea street
mounds view, 
MN 
55304

Applicant Contact rachel u libi
Correspondent
MEDTRONIC, INC.
8200 coral sea street
mounds view, 
MN 
55304

Correspodent Contact rachel u libi
Regulation Number 870.3640
Classification Product Code
KRE  
Subsequent Product Codes
DPS   DXH   OUG  
Date Received 03/11/2011
Decision Date 06/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No