Clearance Summary
HEARTEVENT, MODEL AT received FDA 510(k) clearance under submission number K072385, sponsored by Diagnostic Devices Pty, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-01-11.
- Submission: K072385
- Applicant / Sponsor: Diagnostic Devices Pty, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 2008-01-11
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.