Clearance Summary
OMEGA CARES SYSTEM received FDA 510(k) clearance under submission number K945068, sponsored by J-F Medical Systems Intl., 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 1996-01-25.
- Submission: K945068
- Applicant / Sponsor: J-F Medical Systems Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 1996-01-25
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.