Clearance Summary
CEROX, MODEL 321OF received FDA 510(k) clearance under submission number K100875, sponsored by Or-Nim Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-01-25.
- Submission: K100875
- Applicant / Sponsor: Or-Nim Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2011-01-25
Classification & Regulation
This clearance is catalogued under FDA product code MUD and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.