Clearance Summary
CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR received FDA 510(k) clearance under submission number K060065, sponsored by Oridion Capnography, 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 2006-05-04.
- Submission: K060065
- Applicant / Sponsor: Oridion Capnography, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2006-05-04
Classification & Regulation
This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.