The following data is part of a premarket notification filed by Ptw-freiburg Physikalisch-technische-werkstaetten with the FDA for Octavius I, Octavius Ii, Octavius Iii, Octavius 4d.
| Device ID | K160405 |
| 510k Number | K160405 |
| Device Name: | OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D |
| Classification | Accelerator, Linear, Medical |
| Applicant | PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN LOERRACHER STR.7 Freiburg, DE 79115 |
| Contact | Sandor-csaba Ats |
| Correspondent | Sandor-csaba Ats PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN LOERRACHER STR.7 Freiburg, DE 79115 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-16 |
| Decision Date | 2017-10-20 |
| Summary: | summary |