The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon 60 Degree Fundus Camera Cf-60s.
| Device ID | K844053 |
| 510k Number | K844053 |
| Device Name: | CANON 60 DEGREE FUNDUS CAMERA CF-60S |
| Classification | Coagulator, Culdoscopic (and Accessories) |
| 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 | HFI |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-18 |
| Decision Date | 1984-12-19 |