Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K010315 |
FOIA Releasable 510(k) |
K010315
|
Device Name |
ISCREEN VISION SCREENER |
Applicant |
ISCREEN, LLC. |
668 COLONIAL RD. (SUITE 1) |
MEMPHIS,
TN
38117
|
|
Applicant Contact |
PETER THRALL |
Correspondent |
ISCREEN, LLC. |
668 COLONIAL RD. (SUITE 1) |
MEMPHIS,
TN
38117
|
|
Correspondent Contact |
PETER THRALL |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 02/02/2001 |
Decision Date | 06/01/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|