Clearance Summary
C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP received FDA 510(k) clearance under submission number K821328, sponsored by Medionics International , 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 1982-07-28.
- Submission: K821328
- Applicant / Sponsor: Medionics International , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1982-07-28
Classification & Regulation
This clearance is catalogued under FDA product code KPF and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.