K832762 is an FDA 510(k) clearance for the MILLER/NADLER GLARE TESTER. This device is classified as a Photostimulator, Ac-powered (Class II - Special Controls, product code HLX).
Submitted by Titmus Optical, Inc. (Walker, US). The FDA issued a Cleared decision on September 29, 1983, 44 days after receiving the submission on August 16, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1630.
| 510(k) Number | K832762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 1983 |
| Decision Date | September 29, 1983 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HLX — Photostimulator, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1630 |