Device Classification Name |
blood establishment computer software and accessories
|
510(k) Number |
BK231004 |
Tradename |
Blood Product Questionnaire Module
|
Device Name |
Blood Establishment Computer Software and Accessories |
Original Applicant |
Buoy Software, LLC |
55 post rd west |
westport,
CT
06880
|
|
Regulation Number | 864.9165
|
Classification Product Code |
|
Date Received | 09/08/2023 |
Decision Date | 11/16/2023 |
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
|