Device Classification Name |
Pump, Infusion
|
510(k) Number |
K070125 |
Device Name |
COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION |
Applicant |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
JEME WALLACE |
Correspondent |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD |
MCGAW PARK,
IL
60085
|
|
Correspondent Contact |
JEME WALLACE |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 01/16/2007 |
Decision Date | 04/16/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|