The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon 60 Fundus Camera Cf-60u.
| Device ID | K843021 |
| 510k Number | K843021 |
| Device Name: | CANON 60 FUNDUS CAMERA CF-60U |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CANON U.S.A., INC. Melville, NY 11747 |
| Contact | Eiji Fuse |
| Correspondent | Eiji Fuse CANON U.S.A., INC. Melville, NY 11747 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-01 |
| Decision Date | 1984-10-05 |