Clearance Summary
EK12 V2 Algorithm received FDA 510(k) clearance under submission number K221904, sponsored by Ge Medical Systems Information Technologies, 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 2022-12-20.
- Submission: K221904
- Applicant / Sponsor: Ge Medical Systems Information Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2022-12-20
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.