The following data is part of a premarket notification filed by Hemasoft Software Sl with the FDA for Blood Establishment Computer Software And Accessories.
| Device ID | BK200515 |
| 510k Number | BK200515 |
| Device Name: | Blood Establishment Computer Software And Accessories |
| Classification | Blood Establishment Computer Software And Accessories |
| Applicant | Hemasoft Software SL calle Antonio Lopez, 249 4 Madrid, 28041, |
| 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 | 2020-08-19 |
| Decision Date | 2020-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860007282706 | BK200515 | 0 |