Clearance Summary
ANGIO-FLO MONITORING KIT received FDA 510(k) clearance under submission number K801173, sponsored by Hospital Products Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1980-05-28.
- Submission: K801173
- Applicant / Sponsor: Hospital Products Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1210
- Decision date: 1980-05-28
Classification & Regulation
This clearance is catalogued under FDA product code KRA and 21 CFR 870.1210, within the Cardiovascular review panel as a Class II device.