Clearance Summary
EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION received FDA 510(k) clearance under submission number K002984, sponsored by Cybercare Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-12-18.
- Submission: K002984
- Applicant / Sponsor: Cybercare Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1875
- Decision date: 2000-12-18
Classification & Regulation
This clearance is catalogued under FDA product code DQD and 21 CFR 870.1875, within the Cardiovascular review panel as a Class II device.