Clearance Summary
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 received FDA 510(k) clearance under submission number K982104, sponsored by Medical Data Electronics. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-11-25.
- Submission: K982104
- Applicant / Sponsor: Medical Data Electronics
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1998-11-25
Classification & Regulation
This clearance is catalogued under FDA product code MLD and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.