Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K101419 |
Device Name |
ENSITE VELOCITY SYSTEM, MODEL EE3000 |
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
|
|
Correspondent Contact |
DONNA R LUNAK |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 05/20/2010 |
Decision Date | 06/11/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|