The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Non-mydriatic Retinal Camera, Cr4-45nm Dual.
| Device ID | K895474 |
| 510k Number | K895474 |
| Device Name: | NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CANON U.S.A., INC. 30-2 SHIMOMARUKO 3-CHOME OHTA-KU Tokyo 146, JP |
| Contact | Hirohisa Uchii |
| Correspondent | Hirohisa Uchii CANON U.S.A., INC. 30-2 SHIMOMARUKO 3-CHOME OHTA-KU Tokyo 146, JP |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-11 |
| Decision Date | 1989-10-04 |