The following data is part of a premarket notification filed by Scc Soft Computer with the FDA for Blood Establishment Computer Software And Accessories.
| Device ID | BK200531 |
| 510k Number | BK200531 |
| Device Name: | Blood Establishment Computer Software And Accessories |
| Classification | Blood Establishment Computer Software And Accessories |
| Applicant | SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760 |
| Product Code | MMH |
| CFR Regulation Number | 864.9165 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-05 |
| Decision Date | 2020-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859474006601 | BK200531 | 0 |
| 00810055815647 | BK200531 | 0 |
| 00810055812837 | BK200531 | 0 |