Clearance Summary
CC-100 received FDA 510(k) clearance under submission number K811016, 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 1981-05-01.
- Submission: K811016
- Applicant / Sponsor: Anthro-Metrics Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 1981-05-01
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.