Clearance Summary
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector received FDA 510(k) clearance under submission number K143359, sponsored by Lifewatch Technologies , 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 2015-09-11.
- Submission: K143359
- Applicant / Sponsor: Lifewatch Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2015-09-11
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.