Clearance Summary
CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM received FDA 510(k) clearance under submission number K862375, sponsored by Grandcor Medical Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-07-01.
- Submission: K862375
- Applicant / Sponsor: Grandcor Medical Systems
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1986-07-01
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.