The following data is part of a premarket notification filed by Athlos Oy with the FDA for Dc-air And Athlos-1 And Athlos-air.
| Device ID | K211688 |
| 510k Number | K211688 |
| Device Name: | DC-Air And Athlos-1 And Athlos-Air |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Athlos Oy Klovinpellontie 1-3, Tower 2 Espoo, FI 02180 |
| Contact | Konstantinos Spartiotis |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-06-02 |
| Decision Date | 2021-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 64298105870910 | K211688 | 000 |
| 64298105870606 | K211688 | 000 |
| 06429810587039 | K211688 | 000 |
| 06429810587008 | K211688 | 000 |