Clearance Summary
THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM received FDA 510(k) clearance under submission number K974679, sponsored by Medcon , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1998-03-23.
- Submission: K974679
- Applicant / Sponsor: Medcon , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1600
- Decision date: 1998-03-23
Classification & Regulation
This clearance is catalogued under FDA product code IZI and 21 CFR 892.1600, within the Radiology review panel as a Class II device.