Clearance Summary
ZIO SR ECG Monitoring Service received FDA 510(k) clearance under submission number K143513, sponsored by iRhythm 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 2015-06-19.
- Submission: K143513
- Applicant / Sponsor: iRhythm Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2015-06-19
Classification & Regulation
This clearance is catalogued under FDA product code DSH and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.