Clearance Summary
DATEX-OHMEDA NETWORK AND CENTRAL received FDA 510(k) clearance under submission number K000647, 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 2000-07-13.
- Submission: K000647
- Applicant / Sponsor: Datex-Ohmeda, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2000-07-13
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.