The following data is part of a premarket notification filed by Sunquest Information Systems, Inc. with the FDA for Blood Establishment Computer Software And Accessories.
| Device ID | BK210556 |
| 510k Number | BK210556 |
| Device Name: | Blood Establishment Computer Software And Accessories |
| Classification | Blood Establishment Computer Software And Accessories |
| Applicant | Sunquest Information Systems, Inc. 3330 East Sunrise Dr Tucson, AZ 85718 |
| 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 | 2021-02-19 |
| Decision Date | 2021-04-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B236TRM3000 | BK210556 | 0 |