Device Classification Name |
ophthalmoscope, ac-powered
|
510(k) Number |
K120057 |
Device Name |
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) |
Applicant |
BIOPTIGEN, INC. |
104 T.W. ALEXANDER DRIVE |
P.O. BOX 13569 |
DURHAM,
NC
27709
|
|
Applicant Contact |
DAWN REILLY-O'DELL |
Correspondent |
BIOPTIGEN, INC. |
104 T.W. ALEXANDER DRIVE |
P.O. BOX 13569 |
DURHAM,
NC
27709
|
|
Correspondent Contact |
DAWN REILLY-O'DELL |
Regulation Number | 886.1570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/09/2012 |
Decision Date | 05/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|