Clearance Summary
OPD-SCAN, MODELS ARK-10000 AND ARK-9000 received FDA 510(k) clearance under submission number K003299, sponsored by Nidek Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2001-03-09.
- Submission: K003299
- Applicant / Sponsor: Nidek Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1350
- Decision date: 2001-03-09
Classification & Regulation
This clearance is catalogued under FDA product code HLQ and 21 CFR 886.1350, within the Ophthalmic review panel as a Class I device.