Clearance Summary
DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK received FDA 510(k) clearance under submission number K922074, sponsored by Danby Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1993-01-22.
- Submission: K922074
- Applicant / Sponsor: Danby Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1993-01-22
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.