Clearance Summary
EyeCTester received FDA 510(k) clearance under submission number K203594, sponsored by Neuro-Eye Diagnostic Systems, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2022-09-07.
- Submission: K203594
- Applicant / Sponsor: Neuro-Eye Diagnostic Systems, LLC
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1330
- Decision date: 2022-09-07
Classification & Regulation
This clearance is catalogued under FDA product code QTW and 21 CFR 886.1330, within the Ophthalmic review panel as a Class I device.