The following data is part of a premarket notification filed by Topcon Corp. with the FDA for Non-mydriatic Retinal Camera, Model Trc-nw8f.
| Device ID | K100207 |
| 510k Number | K100207 |
| Device Name: | NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | TOPCON CORP. 75-1 HASUNUMA-CHO ITABASHI-KU Tokyo, JP 174-8580 |
| Contact | Takao Sugawara |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-01-25 |
| Decision Date | 2010-02-12 |
| Summary: | summary |