K940516 is an FDA 510(k) clearance for the AUTO REFF-30. This device is classified as a Refractometer, Ophthalmic (Class I - General Controls, product code HKO).
Submitted by Canon, Inc. (Ohta-Ku, Tokyo, Japan, JP). The FDA issued a Cleared decision on July 12, 1994, 158 days after receiving the submission on February 4, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1760.
| 510(k) Number | K940516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 1994 |
| Decision Date | July 12, 1994 |
| Days to Decision | 158 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 |