Clearance Summary
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX received FDA 510(k) clearance under submission number K012531, 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 2001-11-02.
- Submission: K012531
- Applicant / Sponsor: Datex-Ohmeda
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2001-11-02
Classification & Regulation
This clearance is catalogued under FDA product code MSX and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.