Clearance Summary
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES received FDA 510(k) clearance under submission number K992323, sponsored by Datex-Ohmeda, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-11-01.
- Submission: K992323
- Applicant / Sponsor: Datex-Ohmeda, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1999-11-01
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.