Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K092810 |
Device Name |
EP-WORKMATE SYSTEM, VERSION 4.2 |
Applicant |
ST. JUDE MEDICAL |
575 ROUTE 73 N |
BUILDING D |
WEST BERLIN,
NJ
08901
|
|
Applicant Contact |
TIMOTHY J KAPPERS |
Correspondent |
ST. JUDE MEDICAL |
575 ROUTE 73 N |
BUILDING D |
WEST BERLIN,
NJ
08901
|
|
Correspondent Contact |
TIMOTHY J KAPPERS |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 09/11/2009 |
Decision Date | 10/09/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|