Device Classification Name |
Pump, Infusion
|
510(k) Number |
K040114 |
Device Name |
ABBOTT DATA PORT PC, MODEL 12181 |
Applicant |
ABBOTT LABORATORIES |
D-389, BLDG. J45-2 |
200 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -6157
|
|
Applicant Contact |
PATRICIA MELERSKI |
Correspondent |
ABBOTT LABORATORIES |
D-389, BLDG. J45-2 |
200 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -6157
|
|
Correspondent Contact |
PATRICIA MELERSKI |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 01/20/2004 |
Decision Date | 01/29/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|