| Device Classification Name |
blood establishment computer software and accessories
|
| 510(k) Number |
BK060037 |
| Tradename |
Cerner Bridge Medical Transfusion Administration and Specimen Collections
|
| Device Name |
Blood Establishment Computer Software and Accessories |
| Original Applicant |
| Cerner Corporation |
| 2800 rock creek parkway |
|
kansas city,
MO
64117
2551
|
|
| Regulation Number | 864.9165
|
| Classification Product Code |
|
| Date Received | 07/03/2006 |
| Decision Date | 05/24/2007 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
Hematology
|
| Review Advisory Committee |
Hematology
|
| Type |
510(k) Traditional
|
| Total Product Life Cycle (TPLC) |
TPLC Device Report
|
| Reviewed by Third Party |
No
|
| Expedited Review |
No
|
| Combination Product |
No
|
| In Vitro Product |
No
|