Clearance Summary
ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 received FDA 510(k) clearance under submission number K921168, sponsored by Allen Medical Systems, Inc.. 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 1993-04-21.
- Submission: K921168
- Applicant / Sponsor: Allen Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5420
- Decision date: 1993-04-21
Classification & Regulation
This clearance is catalogued under FDA product code KZD and 21 CFR 880.5420, within the General Hospital review panel as a Class I device.