K801906 is an FDA 510(k) clearance for the DIOPTRON III AUTOREFRACTOR. This device is classified as a Refractometer, Ophthalmic (Class I - General Controls, product code HKO).
Submitted by Coherent Medical Division (Mchenry, US). The FDA issued a Cleared decision on August 27, 1980, 16 days after receiving the submission on August 11, 1980.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1760.
| 510(k) Number | K801906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1980 |
| Decision Date | August 27, 1980 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HKO — Refractometer, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1760 |