Clearance Summary
MODEL CF-300 THREE CHANNEL FLOW METER received FDA 510(k) clearance under submission number K792190, sponsored by Wilton Webster Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1979-11-21.
- Submission: K792190
- Applicant / Sponsor: Wilton Webster Laboratories
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2060
- Decision date: 1979-11-21
Classification & Regulation
This clearance is catalogued under FDA product code DRQ and 21 CFR 870.2060, within the Cardiovascular review panel as a Class II device.