Device Classification Name |
Pump, Infusion
|
510(k) Number |
K051641 |
Device Name |
ALARIS SYSTEM PC UNIT, MODEL 8001 |
Applicant |
CARDINAL HEALTH, ALARIS PRODUCTS |
10221 WATERIDGE CIRCLE |
SAN DIEGO,
CA
92121 -2772
|
|
Applicant Contact |
STACY L LEWIS |
Correspondent |
CARDINAL HEALTH, ALARIS PRODUCTS |
10221 WATERIDGE CIRCLE |
SAN DIEGO,
CA
92121 -2772
|
|
Correspondent Contact |
STACY L LEWIS |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 06/20/2005 |
Decision Date | 10/20/2005 |
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
|
|
|