Clearance Summary
UNOMEDICAL MONICA INFUSION SET received FDA 510(k) clearance under submission number K032854, sponsored by Unomedical A/S. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2003-10-09.
- Submission: K032854
- Applicant / Sponsor: Unomedical A/S
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2003-10-09
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.