K832843 is an FDA 510(k) clearance for the OSCAR COLOUR VISION TESTER. This device is classified as a Tester, Color Vision (Class I - General Controls, product code HIT).
Submitted by Keeler Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984, 135 days after receiving the submission on August 22, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1170.
| 510(k) Number | K832843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1983 |
| Decision Date | January 04, 1984 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HIT — Tester, Color Vision |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1170 |