Clearance Summary
IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM received FDA 510(k) clearance under submission number K854330, sponsored by Par Technology Park. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1985-12-13.
- Submission: K854330
- Applicant / Sponsor: Par Technology Park
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1120
- Decision date: 1985-12-13
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.