Clearance Summary
IVENT101 received FDA 510(k) clearance under submission number K112754, sponsored by Versamed Medical Systems , 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 2012-06-15.
- Submission: K112754
- Applicant / Sponsor: Versamed Medical Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5895
- Decision date: 2012-06-15
Classification & Regulation
This clearance is catalogued under FDA product code CBK and 21 CFR 868.5895, within the Anesthesiology review panel as a Class II device.