Clearance Summary
SINGLE DOSE DISPENSING PIN, MODEL 2201 received FDA 510(k) clearance under submission number K013087, 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 2001-11-13.
- Submission: K013087
- Applicant / Sponsor: Alaris Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2001-11-13
Classification & Regulation
This clearance is catalogued under FDA product code LHI and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.