Clearance Summary
AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR received FDA 510(k) clearance under submission number K102507, sponsored by Tz Medical, 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 2011-06-13.
- Submission: K102507
- Applicant / Sponsor: Tz Medical, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2011-06-13
Classification & Regulation
This clearance is catalogued under FDA product code DSI and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.