Clearance Summary
OPHTHALMOSCOPE received FDA 510(k) clearance under submission number K925757, sponsored by Rudolf Riester GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1993-08-03.
- Submission: K925757
- Applicant / Sponsor: Rudolf Riester GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 1993-08-03
Classification & Regulation
This clearance is catalogued under FDA product code HLJ and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.