Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K113451 |
Device Name |
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX |
Applicant |
NIDEK TECHNOLOGIES SRL |
VIA DELL ARTIGIANATO, 6/A |
ALBIGNASEGO (PADOVA),
IT
35020
|
|
Applicant Contact |
ENRICO BISSON |
Correspondent |
NIDEK TECHNOLOGIES SRL |
VIA DELL ARTIGIANATO, 6/A |
ALBIGNASEGO (PADOVA),
IT
35020
|
|
Correspondent Contact |
ENRICO BISSON |
Regulation Number | 886.1120
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/21/2011 |
Decision Date | 05/08/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|