Clearance Summary
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES received FDA 510(k) clearance under submission number K013389, 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 2002-01-10.
- Submission: K013389
- Applicant / Sponsor: Datex-Ohmeda
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2002-01-10
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.