Clearance Summary
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA received FDA 510(k) clearance under submission number K130289, sponsored by Topcon Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2013-05-10.
- Submission: K130289
- Applicant / Sponsor: Topcon Corp.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1120
- Decision date: 2013-05-10
Classification & Regulation
This clearance is catalogued under FDA product code HKI and 21 CFR 886.1120, within the Ophthalmic review panel as a Class II device.