Clearance Summary
MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS received FDA 510(k) clearance under submission number K002781, sponsored by Medical Cables, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-11-29.
- Submission: K002781
- Applicant / Sponsor: Medical Cables, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2900
- Decision date: 2000-11-29
Classification & Regulation
This clearance is catalogued under FDA product code DSA and 21 CFR 870.2900, within the Cardiovascular review panel as a Class II device.