Clearance Summary
PARTNER INFUSION SYSTEM: received FDA 510(k) clearance under submission number K896717, sponsored by Q-Life 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 1990-08-02.
- Submission: K896717
- Applicant / Sponsor: Q-Life Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1990-08-02
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.