Clearance Summary
TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM received FDA 510(k) clearance under submission number K100155, sponsored by Biomedical Systems Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-04-20.
- Submission: K100155
- Applicant / Sponsor: Biomedical Systems Corp.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2010-04-20
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.