Clearance Summary
BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA received FDA 510(k) clearance under submission number K020382, 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 2002-06-28.
- Submission: K020382
- Applicant / Sponsor: Medicotest A/S
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 2002-06-28
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.