Clearance Summary
CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING received FDA 510(k) clearance under submission number K112768, sponsored by Calypso Medical Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-11-18.
- Submission: K112768
- Applicant / Sponsor: Calypso Medical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2011-11-18
Classification & Regulation
This clearance is catalogued under FDA product code LHN and 21 CFR 892.5050, within the Radiology review panel as a Class II device.