Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K101935 |
Device Name |
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM |
Applicant |
CENTERVUE SPA |
PIAZZA ALBANIA 10 |
ROME,
IT
00153
|
|
Applicant Contact |
ROGER GRAY |
Correspondent |
CENTERVUE SPA |
PIAZZA ALBANIA 10 |
ROME,
IT
00153
|
|
Correspondent Contact |
ROGER GRAY |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 07/12/2010 |
Decision Date | 10/27/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|