K942242 is an FDA 510(k) clearance for the AUTO REF-KERATOMETER, RK-3. This device is classified as a Refractometer, Ophthalmic (Class I - General Controls, product code HKO).
Submitted by Cannon U.S.A., Inc. (Lake Success, US). The FDA issued a Cleared decision on September 2, 1994, 116 days after receiving the submission on May 9, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1760.
| 510(k) Number | K942242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1994 |
| Decision Date | September 02, 1994 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKO — Refractometer, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1760 |