Clearance Summary
MODEL 404A I.V. INFUSION PUMP ANALYZER received FDA 510(k) clearance under submission number K897096, sponsored by Dynatech/Nevada, 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 1990-03-15.
- Submission: K897096
- Applicant / Sponsor: Dynatech/Nevada, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1990-03-15
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.