Clearance Summary
SMART CAPNOLINE GUARDIAN received FDA 510(k) clearance under submission number K093388, sponsored by Oridion Medical 1987 , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2010-03-04.
- Submission: K093388
- Applicant / Sponsor: Oridion Medical 1987 , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2010-03-04
Classification & Regulation
This clearance is catalogued under FDA product code CCK and 21 CFR 868.1400, within the Anesthesiology review panel as a Class II device.