Clearance Summary
CAPNOMASK received FDA 510(k) clearance under submission number K131339, sponsored by Mediplus , 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 2013-11-25.
- Submission: K131339
- Applicant / Sponsor: Mediplus , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2013-11-25
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.