Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K093942 |
Device Name |
ENSITE VELOCITY SYSTEM V1.3 |
Applicant |
ST. JUDE MEDICAL |
One St. Jude Medical Drive |
St. Paul,
MN
55117
|
|
Applicant Contact |
DONNA LUNAK |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 12/22/2009 |
Decision Date | 02/25/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|