Clearance Summary
BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES received FDA 510(k) clearance under submission number K983689, sponsored by Medicotest A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-01-15.
- Submission: K983689
- Applicant / Sponsor: Medicotest A/S
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1999-01-15
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.