Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K062295 |
Device Name |
IRI INTEGRATED RETINAL IMAGER |
Applicant |
MEDIVISION MEDICAL IMAGING, LTD. |
20 HATA' AS ST |
KFAR SABA,
IL
44425
|
|
Applicant Contact |
AHAVA STEIN |
Correspondent |
MEDIVISION MEDICAL IMAGING, LTD. |
20 HATA' AS ST |
KFAR SABA,
IL
44425
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 08/07/2006 |
Decision Date | 10/20/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|