Clearance Summary
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT received FDA 510(k) clearance under submission number K083828, sponsored by Transoma. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-02-11.
- Submission: K083828
- Applicant / Sponsor: Transoma
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2009-02-11
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.