The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Autoref Lensmeter Rl-10.
| Device ID | K925304 |
| 510k Number | K925304 |
| Device Name: | AUTOREF LENSMETER RL-10 |
| Classification | Refractometer, Ophthalmic |
| Applicant | CANON U.S.A., INC. 30-2 SHIMOMARUKO 3-CHOME OHTA-KU Tokyo 146, JP |
| Contact | Takahashi |
| Correspondent | Takahashi CANON U.S.A., INC. 30-2 SHIMOMARUKO 3-CHOME OHTA-KU Tokyo 146, JP |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-21 |
| Decision Date | 1994-02-17 |