Clearance Summary
CG-6108 ARRHYTHMIA ECG EVENT RECORDER received FDA 510(k) clearance under submission number K060911, sponsored by Card Guard Scientific Survival , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-08-22.
- Submission: K060911
- Applicant / Sponsor: Card Guard Scientific Survival , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 2006-08-22
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.