Clearance Summary
PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED received FDA 510(k) clearance under submission number K913110, sponsored by Microwave Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-10-10.
- Submission: K913110
- Applicant / Sponsor: Microwave Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2060
- Decision date: 1991-10-10
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.