K843304 is an FDA 510(k) clearance for the BINOCULAR INDIRECT OPHTHALMOSCOPE. This device is classified as a Ophthalmoscope, Ac-powered (Class II - Special Controls, product code HLI).
Submitted by Mentor O & O, Inc. (Hingham, US). The FDA issued a Cleared decision on November 21, 1984, 90 days after receiving the submission on August 23, 1984.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K843304 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 1984 |
| Decision Date | November 21, 1984 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HLI — Ophthalmoscope, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |