Device Classification Name |
adaptometer (biophotometer), software-based data acquisition and stimulus generation
|
510(k) Number |
K100954 |
Device Name |
ADAPT, MODEL AX-03SN |
Applicant |
APELIOTUS VISION SCIENCE, INC |
1456 N. MORNINGSIDE DRIVE, NE |
ATLANTA,
GA
30306
|
|
Applicant Contact |
JOHN G EDWARDS |
Correspondent |
APELIOTUS VISION SCIENCE, INC |
1456 N. MORNINGSIDE DRIVE, NE |
ATLANTA,
GA
30306
|
|
Correspondent Contact |
JOHN G EDWARDS |
Regulation Number | 886.1050
|
Classification Product Code |
|
Date Received | 04/07/2010 |
Decision Date | 02/25/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|