The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon Non-mydriatic Retinal Camera Cr4-45nm.
| Device ID | K862323 |
| 510k Number | K862323 |
| Device Name: | CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
| Contact | Tamada |
| Correspondent | Tamada CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-19 |
| Decision Date | 1986-08-21 |