Clearance Summary
COLIN'S MODEL APBM-630 AND QUINTON'S MODEL 470 received FDA 510(k) clearance under submission number K872355, sponsored by Colin Medical Instruments Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1987-09-15.
- Submission: K872355
- Applicant / Sponsor: Colin Medical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1987-09-15
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.