Clearance Summary
CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90 received FDA 510(k) clearance under submission number K853072, sponsored by Camino Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-12-09.
- Submission: K853072
- Applicant / Sponsor: Camino Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 1985-12-09
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.