Clearance Summary
PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) received FDA 510(k) clearance under submission number K082312, sponsored by Heartscape Technologies, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-09-12.
- Submission: K082312
- Applicant / Sponsor: Heartscape Technologies, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2008-09-12
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.