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 |