Clearance Summary
UNICADDY I & II I.V. CONTAINER CADDY IMS POLE MATE received FDA 510(k) clearance under submission number K860468, sponsored by Intl. Medication Systems, 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 1986-03-18.
- Submission: K860468
- Applicant / Sponsor: Intl. Medication Systems, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6990
- Decision date: 1986-03-18
Classification & Regulation
This clearance is catalogued under FDA product code FOX and 21 CFR 880.6990, within the General Hospital review panel as a Class I device.