Clearance Summary
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE received FDA 510(k) clearance under submission number K033078, 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 2003-10-29.
- Submission: K033078
- Applicant / Sponsor: Datex-Ohmeda
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2003-10-29
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.