The following data is part of a premarket notification filed by Cis-us, Inc. with the FDA for Blood Establishment Computer Software And Accessories.
| Device ID | BK960049 |
| 510k Number | BK960049 |
| Device Name: | Blood Establishment Computer Software And Accessories |
| Classification | Blood Establishment Computer Software And Accessories |
| Applicant | CIS-US, Inc. 10 De Angelo Drive Bedford, MA 01730 |
| 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 | 1996-04-25 |
| Decision Date | 1998-03-25 |