Clearance Summary
GENERAL ULTRASOUND EXAM. TABLE received FDA 510(k) clearance under submission number K802254, sponsored by Engineering Dynamics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1980-11-26.
- Submission: K802254
- Applicant / Sponsor: Engineering Dynamics Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 1980-11-26
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.