Clearance Summary
RAHD 3100 received FDA 510(k) clearance under submission number K903313, sponsored by Esm , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1991-10-07.
- Submission: K903313
- Applicant / Sponsor: Esm , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5840
- Decision date: 1991-10-07
Classification & Regulation
This clearance is catalogued under FDA product code KPQ and 21 CFR 892.5840, within the Radiology review panel as a Class II device.