The following data is part of a premarket notification filed by Macromedics Bv with the FDA for Flexboardtm, Eagleboardtm, Breastboard Sxtm.
| Device ID | K213439 |
| 510k Number | K213439 |
| Device Name: | FlexBoardTM, EagleBoardTM, BreastBoard SXTM |
| Classification | Accelerator, Linear, Medical |
| Applicant | MacroMedics BV Oostbaan 670 Moordrecht, NL 2841 ML |
| Contact | Elizabeth Hajos |
| Correspondent | Elizabeth Hajos MacroMedics BV Oostbaan 670 Moordrecht, NL 2841 ML |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-25 |
| Decision Date | 2022-06-24 |