Device Classification Name |
ophthalmoscope, ac-powered
|
510(k) Number |
K964137 |
Device Name |
RTA RETINAL THICKNESS ANALYZER |
Applicant |
TALIA TECHNOLOGY LTD. |
COLUMBIA SQUARE |
555 THIRTEENTH STREET N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
TALIA TECHNOLOGY LTD. |
COLUMBIA SQUARE |
555 THIRTEENTH STREET N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 10/15/1996 |
Decision Date | 02/03/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|