Device Classification Name |
blood establishment computer software and accessories
|
510(k) Number |
BK210556 |
Tradenames |
Sunquest Transfusion Manager,
Sunquest Transfusion Manager Version 3.0
|
Device Name |
Blood Establishment Computer Software and Accessories |
Original Applicant |
Sunquest Information Systems, Inc. |
3330 east sunrise dr |
tucson,
AZ
85718
|
|
Regulation Number | 864.9165
|
Classification Product Code |
|
Date Received | 02/19/2021 |
Decision Date | 04/16/2021 |
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
|
|
|