The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon Auto Keratometer K-1.
| Device ID | K844054 |
| 510k Number | K844054 |
| Device Name: | CANON AUTO KERATOMETER K-1 |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Contact | Uchil |
| Correspondent | Uchil CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-18 |
| Decision Date | 1984-12-19 |