Device Classification Name |
pump, infusion, pca
|
510(k) Number |
K051253 |
Device Name |
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) |
Applicant |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
NANETTE HEDDEN |
Correspondent |
BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD |
MCGAW PARK,
IL
60085
|
|
Correspondent Contact |
NANETTE HEDDEN |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/16/2005 |
Decision Date | 07/15/2005 |
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
|
Recalls |
CDRH Recalls
|
|
|