The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon 60 Zoom Fundus Camera Cf-60za Ophthalmic Cam.
| Device ID | K844898 |
| 510k Number | K844898 |
| Device Name: | CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Contact | Unknown Unknown |
| Correspondent | Unknown Unknown CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-17 |
| Decision Date | 1985-01-22 |