The following data is part of a premarket notification filed by Topcon Corp. with the FDA for Topcon Model Trc-nw200 Non-mydriatic Retinal Camera.
| Device ID | K041367 |
| 510k Number | K041367 |
| Device Name: | TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | TOPCON CORP. 37 WEST CENTURY RD. Paramus, NJ 07652 |
| Contact | Donald H Winfield |
| Correspondent | Donald H Winfield TOPCON CORP. 37 WEST CENTURY RD. Paramus, NJ 07652 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-24 |
| Decision Date | 2004-11-05 |
| Summary: | summary |