Clearance Summary
OPD-STATION SOFTWARE received FDA 510(k) clearance under submission number K050336, sponsored by Nidek, 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 2005-08-24.
- Submission: K050336
- Applicant / Sponsor: Nidek, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1760
- Decision date: 2005-08-24
Classification & Regulation
This clearance is catalogued under FDA product code NCF and 21 CFR 886.1760, within the Ophthalmic review panel as a Class I device.