Clearance Summary
MEDLEY PCA MODULE, MODEL 8120 received FDA 510(k) clearance under submission number K043299, sponsored by Alaris Medical 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 2004-12-10.
- Submission: K043299
- Applicant / Sponsor: Alaris Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2004-12-10
Classification & Regulation
This clearance is catalogued under FDA product code MEA and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.