Clearance Summary
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION received FDA 510(k) clearance under submission number K110535, sponsored by Carefusion 303, 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 2012-03-26.
- Submission: K110535
- Applicant / Sponsor: Carefusion 303, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2012-03-26
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.