Submission Details
| 510(k) Number | K844694 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 03, 1984 |
| Decision Date | January 22, 1985 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
K844694 is an FDA 510(k) clearance for the TITMUS VISION TESTER II, a Tester, Color Vision (Class I — General Controls, product code HIT), submitted by Titmus Optical, Inc. (Petersburg, US). The FDA issued a Cleared decision on January 22, 1985, 50 days after receiving the submission on December 3, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1170.
| 510(k) Number | K844694 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 03, 1984 |
| Decision Date | January 22, 1985 |
| Days to Decision | 50 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 |