The following data is part of a premarket notification filed by Kowa Optimed, Inc. with the FDA for Kowa Professional Fundus Camera Models Fx-500, Fx-500s, Fx-500c.
| Device ID | K954780 |
| 510k Number | K954780 |
| Device Name: | KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | KOWA OPTIMED, INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 |
| Contact | Samia N Rodriguez |
| Correspondent | Samia N Rodriguez KOWA OPTIMED, INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-17 |
| Decision Date | 1995-12-01 |