Clearance Summary
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE received FDA 510(k) clearance under submission number K022740, sponsored by Datex-Ohmeda. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-11-14.
- Submission: K022740
- Applicant / Sponsor: Datex-Ohmeda
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2002-11-14
Classification & Regulation
This clearance is catalogued under FDA product code MLD and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.