510(k) K241649
K241649 is an FDA 510(k) premarket notification submitted by Zinnovi, Inc. for the device "DUO1 and DUO2". The FDA issued a decision of Substantially Equivalent on July 5, 2024. 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
- July 5, 2024
- Date Received
- June 7, 2024
- 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