Device Classification Name |
ophthalmoscope, ac-powered
|
510(k) Number |
K133758 |
Device Name |
CENTERVUE MACULAR INTEGRITY ASSESSMENT |
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 | 886.1570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/11/2013 |
Decision Date | 04/23/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|