Clearance Summary
ETV, ELECTRONIC VISION AID received FDA 510(k) clearance under submission number K884540, sponsored by Sevrain-Tech, 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 1989-01-19.
- Submission: K884540
- Applicant / Sponsor: Sevrain-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5915
- Decision date: 1989-01-19
Classification & Regulation
This clearance is catalogued under FDA product code HPE and 21 CFR 886.5915, within the Ophthalmic review panel as a Class I device.