The following data is part of a premarket notification filed by Dyn'r with the FDA for Sdx-spirodynr'x Radiotherapy Breathing Control.
| Device ID | K092479 |
| 510k Number | K092479 |
| Device Name: | SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL |
| Classification | Accelerator, Linear, Medical |
| Applicant | DYN'R 73 RUE LOUGE Muret, FR 31600 |
| Contact | Xavier Isnard |
| Correspondent | Xavier Isnard DYN'R 73 RUE LOUGE Muret, FR 31600 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-13 |
| Decision Date | 2010-01-11 |
| Summary: | summary |