Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K130656 |
Device Name |
IFUSION |
Applicant |
OPTOVUE, INC. |
2800 Bayview Dr |
FREMONT,
CA
94538
|
|
Applicant Contact |
WILLIAM "BILL" JACKSON |
Correspondent |
OPTOVUE, INC. |
2800 Bayview Dr |
FREMONT,
CA
94538
|
|
Correspondent Contact |
WILLIAM "BILL" JACKSON |
Regulation Number | 886.1120
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/12/2013 |
Decision Date | 07/03/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|