The following data is part of a premarket notification filed by Nidek Technologies Srl with the FDA for Non-mydriatic Auto Fundus Camera Afc-330 With Image Filing Software Na Vis-ex.
| Device ID | K113451 |
| 510k Number | K113451 |
| Device Name: | NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | NIDEK TECHNOLOGIES SRL VIA DELL ARTIGIANATO, 6/A Albignasego (padova), IT 35020 |
| Contact | Enrico Bisson |
| Correspondent | Enrico Bisson NIDEK TECHNOLOGIES SRL VIA DELL ARTIGIANATO, 6/A Albignasego (padova), IT 35020 |
| Product Code | HKI |
| Subsequent Product Code | NFF |
| Subsequent Product Code | NFG |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2012-05-08 |
| Summary: | summary |