Clearance Summary
SACCADOMETER PLUS, SACCADOMETER ADVANCED received FDA 510(k) clearance under submission number K152890, sponsored by Ober Consulting Sp. Z.O.O.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2016-08-11.
- Submission: K152890
- Applicant / Sponsor: Ober Consulting Sp. Z.O.O.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1510
- Decision date: 2016-08-11
Classification & Regulation
This clearance is catalogued under FDA product code HLL and 21 CFR 886.1510, within the Ophthalmic review panel as a Class II device.