The following data is part of a premarket notification filed by Topcon Corporation with the FDA for Trc-nw400 Non-mydriatic Retinal Camera.
Device ID | K141481 |
510k Number | K141481 |
Device Name: | TRC-NW400 NON-MYDRIATIC RETINAL CAMERA |
Classification | Camera, Ophthalmic, Ac-powered |
Applicant | TOPCON CORPORATION 5 TIMBER LANE North Reading, MA 01864 |
Contact | Maureen O'connell |
Correspondent | Maureen O'connell TOPCON CORP. 5 TIMBER LANE North Reading, MA 01864 |
Product Code | HKI |
CFR Regulation Number | 886.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-04 |
Decision Date | 2014-09-17 |
Summary: | summary |