The following data is part of a premarket notification filed by Aurora Technology Development, Llc with the FDA for Adaptivo.
| Device ID | K152994 |
| 510k Number | K152994 |
| Device Name: | Adaptivo |
| Classification | Accelerator, Linear, Medical |
| Applicant | Aurora Technology Development, LLC 555 D'Onofrio Dr., Suite 104 Madison, WI 53719 |
| Contact | Gustavo H Olivera |
| Correspondent | Thomas Kroenke SPEED TO MARKET, INC. PO BOX 3018 Nederland, CO 80466 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-13 |
| Decision Date | 2016-02-03 |
| Summary: | summary |