Clearance Summary
MODULAR VOLUMETRIC INFUSION PUMP SYS received FDA 510(k) clearance under submission number K843274, sponsored by American Edwards Laboratories. 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 1984-10-19.
- Submission: K843274
- Applicant / Sponsor: American Edwards Laboratories
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1984-10-19
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.