Clearance Summary
EAGLESOFT CHAIRSIDE received FDA 510(k) clearance under submission number K982422, sponsored by Eaglesoft, A Patterson Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1998-09-30.
- Submission: K982422
- Applicant / Sponsor: Eaglesoft, A Patterson Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1998-09-30
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.