Clearance Summary
DATEX-OHMEDA OXY-AFR SENSOR received FDA 510(k) clearance under submission number K042891, 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 2005-06-29.
- Submission: K042891
- Applicant / Sponsor: Datex-Ohmeda
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2005-06-29
Classification & Regulation
This clearance is catalogued under FDA product code NLF and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.