Clearance Summary
EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION received FDA 510(k) clearance under submission number K003257, sponsored by Cybercare Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2000-12-22.
- Submission: K003257
- Applicant / Sponsor: Cybercare Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2000-12-22
Classification & Regulation
This clearance is catalogued under FDA product code CGA and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.