Clearance Summary
CORNING 2500 CO-OXIMETER received FDA 510(k) clearance under submission number K830590, sponsored by Corning Medical & Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1983-04-05.
- Submission: K830590
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7500
- Decision date: 1983-04-05
Classification & Regulation
This clearance is catalogued under FDA product code KHG and 21 CFR 864.7500, within the Hematology review panel as a Class II device.