Clearance Summary
HILL-ROM PRIMAVIEW MONITOR SYSTEM received FDA 510(k) clearance under submission number K013709, sponsored by Hill-Rom, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-11-16.
- Submission: K013709
- Applicant / Sponsor: Hill-Rom, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2001-11-16
Classification & Regulation
This clearance is catalogued under FDA product code FET and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.