ENSITE VELOCITY SYSTEM V.3.0


Device Classification Name

computer, diagnostic, programmable

510(k) Number K112688
Device Name ENSITE VELOCITY SYSTEM V.3.0
Applicant
ST. JUDE MEDICAL
one st. jude medical drive
st. paul, 
MN 
55117

Applicant Contact donna r lunak
Correspondent
ST. JUDE MEDICAL
one st. jude medical drive
st. paul, 
MN 
55117

Correspodent Contact donna r lunak
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 09/15/2011
Decision Date 11/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No