Clearance Summary
BICARBONATE MIXING SYSTEM received FDA 510(k) clearance under submission number K864942, sponsored by Morris Tool , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1987-03-10.
- Submission: K864942
- Applicant / Sponsor: Morris Tool , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1987-03-10
Classification & Regulation
This clearance is catalogued under FDA product code KPO and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.