Device Classification Name |
tomography, optical coherence
|
510(k) Number |
K163475 |
Device Name |
iVue |
Applicant |
Optovue, Inc. |
2800 Bayview Drive |
Fremont,
CA
94538
|
|
Applicant Contact |
Edward J. Sinclair |
Correspondent |
Optovue, Inc. |
2800 Bayview Drive |
Fremont,
CA
94538
|
|
Correspondent Contact |
Edward J. Sinclair |
Regulation Number | 886.1570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/12/2016 |
Decision Date | 06/09/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02775097 NCT02781948
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|