Clearance Summary
CARDIOSTRESS received FDA 510(k) clearance under submission number K820011, sponsored by Instruments For Cardiac Research. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1982-01-22.
- Submission: K820011
- Applicant / Sponsor: Instruments For Cardiac Research
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 1982-01-22
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.