Clearance Summary
FIDELITY 200 CARDIAC EVENT RECORDER received FDA 510(k) clearance under submission number K071228, sponsored by Signalife, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-11-21.
- Submission: K071228
- Applicant / Sponsor: Signalife, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 2007-11-21
Classification & Regulation
This clearance is catalogued under FDA product code DXH and 21 CFR 870.2920, within the Cardiovascular review panel as a Class II device.