Device Classification Name |
Pump, Infusion
|
510(k) Number |
K032147 |
Device Name |
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES |
Applicant |
ALARIS MEDICAL SYSTEMS, INC. |
10221 WATERIDGE CIR. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
STACY L LEWIS |
Correspondent |
ALARIS MEDICAL SYSTEMS, INC. |
10221 WATERIDGE CIR. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
STACY L LEWIS |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/14/2003 |
Decision Date | 07/25/2003 |
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
|
Recalls |
CDRH Recalls
|
|
|