Clearance Summary
AP 34 MULTI-THERAPY INFUSION PUMP received FDA 510(k) clearance under submission number K082182, sponsored by Q-Core, 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 2008-08-15.
- Submission: K082182
- Applicant / Sponsor: Q-Core, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2008-08-15
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.