The following data is part of a premarket notification filed by Biq-health Solutions, Lda with the FDA for Blood Establishment Computer Software And Accessories.
| Device ID | BK210593 |
| 510k Number | BK210593 |
| Device Name: | Blood Establishment Computer Software And Accessories |
| Classification | Blood Establishment Computer Software And Accessories |
| Applicant | BIQ-Health Solutions, Lda rua Ferreira De Castro, 20c Barcarena, Lisbon, 2730-081, PORTUGAL |
| 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 | 2021-05-26 |
| Decision Date | 2021-08-13 |