The following data is part of a premarket notification filed by Canon, Inc. with the FDA for Auto Reff-30.
| Device ID | K940516 |
| 510k Number | K940516 |
| Device Name: | AUTO REFF-30 |
| Classification | Refractometer, Ophthalmic |
| Applicant | CANON, INC. 30-2 SHIMOMARUKO 3-CHOME Ohta-ku, Tokyo, Japan, JP 146 |
| Contact | H. Uchii |
| Correspondent | H. Uchii CANON, INC. 30-2 SHIMOMARUKO 3-CHOME Ohta-ku, Tokyo, Japan, JP 146 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-04 |
| Decision Date | 1994-07-12 |