Clearance Summary
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 received FDA 510(k) clearance under submission number K000660, 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 2000-03-28.
- Submission: K000660
- Applicant / Sponsor: Medical Data Electronics
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5550
- Decision date: 2000-03-28
Classification & Regulation
This clearance is catalogued under FDA product code DRO and 21 CFR 870.5550, within the Cardiovascular review panel as a Class II device.