Clearance Summary
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 received FDA 510(k) clearance under submission number K073147, sponsored by Transoma Medical. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-12-03.
- Submission: K073147
- Applicant / Sponsor: Transoma Medical
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2007-12-03
Classification & Regulation
This clearance is catalogued under FDA product code MXC and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.