Clearance Summary
TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY received FDA 510(k) clearance under submission number K010505, sponsored by Brentwood Medical Technology Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-03-09.
- Submission: K010505
- Applicant / Sponsor: Brentwood Medical Technology Corp.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2001-03-09
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.