510(k) K230732
K230732 is an FDA 510(k) premarket notification submitted by Alliage S/A Industrias Medica Odontológico. for the device "Eagle S/Saevo Slim/D700 Slim". The FDA issued a decision of Substantially Equivalent on April 11, 2023. 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
- April 11, 2023
- Date Received
- March 16, 2023
- 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