510(k) K211688
K211688 is an FDA 510(k) premarket notification submitted by Athlos OY for the device "DC-Air and Athlos-1 and Athlos-Air". The FDA issued a decision of Substantially Equivalent on Jul 22, 2021. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 22, 2021
- Date Received
- Jun 2, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type
- 510(k)