The following data is part of a premarket notification filed by Macoproductions S.a.s. with the FDA for Blood Mixing Device, Semi-automated.
| Device ID | BK160095 |
| 510k Number | BK160095 |
| Device Name: | Blood Mixing Device, Semi-automated |
| Classification | Device, Mixing And Weighing, Semi-automated |
| Applicant | MacoProductions S.A.S. 200 Chaussee Fernand Forest Tourcoing, 59200, FR |
| Product Code | MYJ |
| CFR Regulation Number | 864.9195 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-30 |
| Decision Date | 2017-08-11 |