The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon Autoref R-10.
| Device ID | K841861 |
| 510k Number | K841861 |
| Device Name: | CANON AUTOREF R-10 |
| Classification | Refractometer, Ophthalmic |
| Applicant | CANON U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-04 |
| Decision Date | 1984-10-05 |