Clearance Summary
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES received FDA 510(k) clearance under submission number K023459, sponsored by Datex-Ohmeda. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-01-13.
- Submission: K023459
- Applicant / Sponsor: Datex-Ohmeda
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2003-01-13
Classification & Regulation
This clearance is catalogued under FDA product code OLW and 21 CFR 882.1400, within the Neurology review panel as a Class II device.