Clearance Summary
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR received FDA 510(k) clearance under submission number K031124, sponsored by Datex-Ohmeda, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-12-04.
- Submission: K031124
- Applicant / Sponsor: Datex-Ohmeda, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2003-12-04
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.