Clearance Summary
BLOOD FLOW ANALYZER received FDA 510(k) clearance under submission number K820959, sponsored by Biofax Medical Instrumentation 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 1982-05-25.
- Submission: K820959
- Applicant / Sponsor: Biofax Medical Instrumentation Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 1982-05-25
Classification & Regulation
This clearance is catalogued under FDA product code DSB and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.