Clearance Summary
THE ADDITION received FDA 510(k) clearance under submission number K102683, sponsored by Ob The-Addition, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-01-06.
- Submission: K102683
- Applicant / Sponsor: Ob The-Addition, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2011-01-06
Classification & Regulation
This clearance is catalogued under FDA product code MUI and 21 CFR 892.1570, within the Radiology review panel as a Class II device.