Clearance Summary
C.A.P.D. AUTOMATIC HEATER PDH 200 received FDA 510(k) clearance under submission number K842305, 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 1984-06-25.
- Submission: K842305
- Applicant / Sponsor: Medionics International , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1984-06-25
Classification & Regulation
This clearance is catalogued under FDA product code FKX and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.