Clearance Summary
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES received FDA 510(k) clearance under submission number K012837, sponsored by Datex-Ohmeda. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-09-14.
- Submission: K012837
- Applicant / Sponsor: Datex-Ohmeda
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2001-09-14
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.