Clearance Summary
INFU BOX TYPE 0412A received FDA 510(k) clearance under submission number K120860, sponsored by Medical Rescue Equipment Holding AS. 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 2012-05-08.
- Submission: K120860
- Applicant / Sponsor: Medical Rescue Equipment Holding AS
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2012-05-08
Classification & Regulation
This clearance is catalogued under FDA product code LGZ and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.