K925755 is an FDA 510(k) clearance for the DE LUXE. This device is classified as a Ophthalmoscope, Battery-powered (Class II - Special Controls, product code HLJ).
Submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on December 3, 1993, 385 days after receiving the submission on November 13, 1992.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K925755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | November 13, 1992 |
| Decision Date | December 03, 1993 |
| Days to Decision | 385 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HLJ — Ophthalmoscope, Battery-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |