Clearance Summary
PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE received FDA 510(k) clearance under submission number K974387, sponsored by Microwave Medical Systems, Inc.. 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 1999-09-01.
- Submission: K974387
- Applicant / Sponsor: Microwave Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1999-09-01
Classification & Regulation
This clearance is catalogued under FDA product code KDJ and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.