The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for 60 Fundus Camera Cf-60uv.
| Device ID | K946058 |
| 510k Number | K946058 |
| Device Name: | 60 FUNDUS CAMERA CF-60UV |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Contact | Hiroyuki Takahashi |
| Correspondent | Hiroyuki Takahashi 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 | 1994-11-08 |
| Decision Date | 1995-02-03 |