Clearance Summary
CC-201 ECG MONITORING SYSTEMS received FDA 510(k) clearance under submission number K813287, sponsored by Anthro-Metrics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1981-12-14.
- Submission: K813287
- Applicant / Sponsor: Anthro-Metrics Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1981-12-14
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.