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 | K901839 |
| 510k Number | K901839 |
| Device Name: | 60 FUNDUS CAMERA CF-60UV |
| Classification | Lens, Fundus, Hruby, Diagnostic |
| Applicant | CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
| Contact | Takahashi |
| Correspondent | Takahashi CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
| Product Code | HJI |
| CFR Regulation Number | 886.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-24 |
| Decision Date | 1990-07-05 |