K945640 is an FDA 510(k) clearance for the RI-SCOPE S OTOSCOPE. 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 January 17, 1995, 62 days after receiving the submission on November 16, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K945640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | November 16, 1994 |
| Decision Date | January 17, 1995 |
| Days to Decision | 62 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 |