Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K023112 |
Device Name |
PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 |
Applicant |
PROBLEM SOLVING CONCEPTS, INC. |
8020 CASTLEWAY DR, SUITE 120 |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
THOMAS M MCCLELLAND |
Correspondent |
PROBLEM SOLVING CONCEPTS, INC. |
8020 CASTLEWAY DR, SUITE 120 |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
THOMAS M MCCLELLAND |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 09/19/2002 |
Decision Date | 12/17/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|