Clearance Summary
ANISEIKONIA INSPECTOR received FDA 510(k) clearance under submission number K013110, sponsored by Optical Diagnostics, 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 2001-12-19.
- Submission: K013110
- Applicant / Sponsor: Optical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1340
- Decision date: 2001-12-19
Classification & Regulation
This clearance is catalogued under FDA product code HJT and 21 CFR 886.1340, within the Ophthalmic review panel as a Class I device.