Clearance Summary
MODIFICATION TO EDI VERIS SYSTEM received FDA 510(k) clearance under submission number K003442, sponsored by Electro-Diagnostic Imaging, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2001-05-04.
- Submission: K003442
- Applicant / Sponsor: Electro-Diagnostic Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1630
- Decision date: 2001-05-04
Classification & Regulation
This clearance is catalogued under FDA product code HLX and 21 CFR 886.1630, within the Ophthalmic review panel as a Class II device.