K924790 is an FDA 510(k) clearance for the BURTON AUTO REFRACTOR - MODEL BAR-7. This device is classified as a Refractometer, Ophthalmic (Class I - General Controls, product code HKO).
Submitted by R.H. Burton Co. (Grove City, US). The FDA issued a Cleared decision on April 5, 1993, 194 days after receiving the submission on September 23, 1992.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1760.
| 510(k) Number | K924790 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 1992 |
| Decision Date | April 05, 1993 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HKO — Refractometer, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1760 |